Methods for targeting a body passage to effect fluid flow

ABSTRACT

A device includes a first end portion, a second end portion, an intermediate portion, and a graft material. The first end portion has a first end diameter. The second end portion has a second end diameter smaller than the first end diameter. The first end portion comprises a first material. The second end portion comprises a second material different than the first material. The intermediate portion is between the first end portion and the second end portion. The intermediate portion tapers between the first end portion and the second end portion. The graft material is coupled to at least the intermediate portion.

INCORPORATION BY REFERENCE

This application is a continuation of U.S. patent application Ser. No.16/552,241, filed on Aug. 27, 2019, which is a continuation of U.S.patent application Ser. No. 16/410,932, filed on May 13, 2019 and issuedas U.S. Pat. No. 10,405,967 on Sep. 10, 2019, which is a continuation ofU.S. patent application Ser. No. 15/648,695, filed on Jul. 13, 2017 andissued as U.S. Pat. No. 10,285,800 on May 14, 2019, which is acontinuation of U.S. patent application Ser. No. 15/084,999, filed onMar. 30, 2016 and issued as U.S. Pat. No. 9,706,998 on Jul. 18, 2017,which is a continuation of U.S. patent application Ser. No. 14/834,813,filed on Aug. 25, 2015 and issued as U.S. Pat. No. 9,314,329 on Apr. 19,2016, which claims the benefit under 35 U.S.C. § 120 and 35 U.S.C. §365(c) as a continuation of International Application No.PCT/US2014/019607 designating the United States, with an internationalfiling date of Feb. 28, 2014, which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent App. No. 61/901,753, filed on Nov. 8,2013, and International Application No. PCT/US2014/019607 is acontinuation-in-part of U.S. patent application Ser. No. 13/791,185,filed on Mar. 8, 2013, each of which is hereby incorporated by referencein its entirety. U.S. patent application Ser. No. 11/662,128, filed onJan. 3, 2008, U.S. patent application Ser. No. 14/141,913, filed on Dec.27, 2013, U.S. patent application Ser. No. 14/592,128, filed on Jan. 8,2015 and issued as U.S. Pat. No. 9,532,803 on Jan. 3, 2017, and U.S.patent application Ser. No. 12/297,498, filed on Feb. 25, 2009 as anational phase of PCT/GB2007/001430, filed Apr. 20, 2007, and issued asU.S. Pat. No. 8,439,963 on May 14, 2013, are hereby incorporated byreference in their entirety.

BACKGROUND Field

The present application relates to methods and systems for use inpercutaneous interventional surgery. In particular, the presentapplication relates to methods and systems for providing or maintainingfluid flow through body passages such as heart cavities and bloodvessels.

Description of the Related Art

Minimally invasive percutaneous surgery, or “key-hole” surgery, is asurgical technique in which surgical devices are inserted into apatient's body cavity through a small aperture cut in the skin. Thisform of surgery has become increasingly popular as it allows patients toendure less surgical discomfort while retaining the benefits ofconventional surgery. Patients treated by such techniques are exposed tolower levels of discomfort, need for general anesthesia, trauma, andrisk of infection, and their recovery times can be significantly reducedcompared to conventional surgical procedures.

Key-hole surgery can be used, for example, for laparoscopic surgery andto treat cardiovascular diseases. In treating cardiovascular diseases,balloon angioplasty, in which a balloon catheter is inserted into anartery usually near the patient's groin and guided to the patient'sheart where a balloon at a distal portion of the catheter is inflated towiden or dilate an occluded vessel to help restore blood flow to thecardiac tissue, may be used to treat a partially occluded coronaryartery as an alternative to open heart surgery. A tubular supportingdevice (e.g., stent) may be deployed at the site of the blockage toprevent future occlusion (restenosis) or collapse of the blood vessel.The stent may, for example, be an expandable metal mesh tube carried onthe balloon of the balloon catheter, or be self-expanding. Theballoon-expandable stent expands when the balloon is inflated, so thatthe stent pushes against the wall of the blood vessel. The stent isarranged to retain its expanded shape when it reaches its expandedposition, for example by plastic deformation or by means of a mechanicallocking mechanism, so as to form a resilient scaffold or support in theblood vessel. The support structure (e.g., stent) supports and dilatesthe wall of the blood vessel to maintain a pathway for blood to flowthrough the vessel. Self-expanding stents are also available, which areheld in a collapsed state by a suitably adapted catheter for transportthrough the artery and which adopt an expanded state when deployed atthe site of the blockage. The catheter may, for example, include aretaining sleeve which retains the stent in a compressed or unexpandedstate. Upon removal or withdrawal of the sleeve from the stent, thestent expands to support and dilate the wall of the blood vessel.

Balloon angioplasty is not always a suitable measure, for example inacute cases and in cases where a coronary artery is completely occluded.In these instances, the typical treatment is to employ coronary bypass.Coronary bypass surgery is an open-chest or open-heart procedure, andtypically involves grafting a piece of healthy blood vessel onto thecoronary artery so as to bypass the blockage and restore blood flow tothe coronary tissue. The healthy blood vessel is usually a veinharvested from the patient's leg or arm during the course of the bypassoperation. To perform the procedure, the patient's heart must be exposedby opening the chest, separating the breastbone, and cutting thepericardium surrounding the heart, resulting in significant surgicaltrauma.

Conventional coronary bypass surgery is not always an option. Certainpatients are unsuitable as candidates for conventional coronary bypasssurgery due low expectation of recovery or high risk from thesignificant trauma due to surgery, high risk of infection, absence ofhealthy vessels to use as bypass grafts, significant co-morbidities, andexpected long and complicated recovery time associated with open-chestsurgery. For example, factors such as diabetes, age, obesity, andsmoking may exclude a proportion of candidate patients who are ingenuine need of such treatment.

SUMMARY

The present application provides methods and systems for overcomingcertain deficiencies and/or improving percutaneous methods and systems.For example, according to several embodiments, the methods and systemsdescribed herein can improve targeting and localization of therapyadministration, which may advantageously provide treatment viapercutaneous techniques to patients unsuitable for more invasivesurgery. Certain embodiments described herein can provide fluid flow inpassages such as coronary and/or peripheral blood vessels by creating abypass using minimally invasive percutaneous surgical techniques.

In some implementations, a method of diverting fluid flow from a firstpassage to a second passage comprises deploying a device in a thirdpassage between the first passage and the second passage. The devicecomprises a first end portion, a second portion, an intermediateportion, and a graft material. The first end portion has a first enddiameter. The second end portion has a second end diameter larger thanthe first end diameter. The intermediate portion is between the firstend portion and the second end portion. The intermediate portion tapersbetween the first end portion and the second end portion. The graftmaterial is coupled to at least the intermediate portion. The methodfurther comprises expanding the first end portion against sidewalls ofthe first passage and expanding the second end portion against sidewallsof the second passage.

The first passage may be an artery and the second passage may be a vein.The first passage may be a coronary artery and the second passage may bea coronary vein. The method may further comprise dilating the thirdpassage. The first passage may be a peripheral artery and the secondpassage may be a peripheral vein. The method may further comprisedilating the third passage. Dilating the third passage may compriseexpanding the intermediate portion. The first passage may besubstantially parallel to the second passage. The intermediate portionmay be conformable to an “S” shape. Expanding the first end portion andthe second end portion may comprise allowing self-expansion of the firstend portion and the second end portion. Expanding the first end portionand the second end portion may comprise balloon expanding at least oneof the first end portion and the second end portion. Expanding one ofthe first end portion and the second end portion may comprise allowingself-expansion of the one of the first end portion and the second endportion and expanding the other of the first end portion and the secondend portion may comprise balloon expanding the other of the first endportion and the second end portion. The method may further compriseexpanding the intermediate portion.

In some implementations, a device comprises a first end portion, asecond end portion, an intermediate portion, and a graft material. Thefirst end portion has a first end diameter. The second end portion has asecond end diameter smaller than the first end diameter. Theintermediate portion is between the first end portion and the second endportion. The intermediate portion tapers between the first end portionand the second end portion. The graft material is coupled to at leastthe intermediate portion.

At least one of the first end portion and the second end portion may besubstantially cylindrical. The first end portion may be substantiallycylindrical and the second end portion may be substantially cylindrical.The first end portion may taper between the first end diameter and theintermediate portion or the second end portion may taper between thesecond end diameter and the intermediate portion. The first end portionmay taper between the first end diameter and the intermediate portionand the second end portion may taper between the second end diameter andthe intermediate portion. The first end portion may comprise a firsttype of material, the second end portion may comprise a second type ofmaterial, and the intermediate portion may comprise a third type ofmaterial. The first type of material may comprise a first cut material,the second type of material may comprise a second cut material, and thethird type of material may comprise filaments. The first cut materialmay comprise a chromium cobalt alloy, the second cut material maycomprise nitinol, and the filaments may comprise nitinol. The first typeof material may comprise a cut material, the second type of material maycomprise the cut material, and the third type of material may comprisefilaments. The cut material may comprise nitinol and the filaments maycomprise nitinol. At least one of the first end portion, the second endportion, the intermediate portion, and the graft material may comprise abioabsorbable material. At least some of the graft material may beoutside the intermediate portion. At least some of the graft materialmay be inside the intermediate portion. At least some of the graftmaterial may be embedded within the intermediate portion. The device maybe capable of maintaining, or configured to maintain, fluid flow betweena first passage in which the first end portion is anchored and a secondpassage in which the second end portion is anchored. The first passagemay be substantially parallel to the second passage. The intermediateportion may be conformable to an “S” shape.

In some implementations, a device comprises a first end portion, asecond end portion, an intermediate portion, and a graft material. Thefirst end portion comprises a first material. The second end portioncomprises a second material different than the first material. Theintermediate portion is between the first end portion and the second endportion. The graft material is coupled to at least the intermediateportion.

The first material may comprise nitinol and the second material maycomprise chromium cobalt. The first material may comprise nitinol andthe second material may comprise stainless steel. The first end portionmay comprise cut struts and the second end portion may comprisefilaments. The first end portion may comprise cut struts and the secondend portion may comprise cut struts. The first material may comprise analloy and the first end portion may comprise struts or filaments havinga first thickness, and the second material may comprise the alloy andthe second end potion may comprise struts or filaments having a secondthickness different than the first thickness. The intermediate portionmay comprise a third material. The third material may comprise nitinol.The intermediate portion may comprise filaments. The intermediateportion may comprise cut struts. At least one of the first end portionand the second end portion may be substantially cylindrical. At leastone of the first end portion, the second end portion, the intermediateportion, and the graft material may comprise a bioabsorbable material.At least some of the graft material may be outside the intermediateportion. At least some of the graft material may be inside theintermediate portion. At least some of the graft material may beembedded within the intermediate portion. The graft material may becoupled to at least one of the first end portion and the second endportion. The device may be capable of maintaining, or configured tomaintain, fluid flow between a first passage in which the first endportion is anchored and a second passage in which the second end portionis anchored. The first passage may be substantially parallel to thesecond passage. The intermediate portion may be conformable to an “S”shape.

In some implementations, a device comprises a support structure and agraft material. The support structure comprises a first end portion, asecond end portion, and an intermediate portion between the first endportion and the second end portion. At least one of the first endportion, the second end portion, and the intermediate portion comprisecut struts and at least one of the first end portion, the second endportion, and the intermediate portion comprise filaments. The graftmaterial is coupled to at least the intermediate portion.

The first end portion and the second end portion comprise cut struts andthe intermediate portion may comprise filaments. At least some of thegraft material may be outside the intermediate portion. At least some ofthe graft material may be inside the intermediate portion. At least someof the graft material may be embedded within the intermediate portion.The graft material may be coupled to at least one of the first endportion and the second end portion. The device may be capable ofmaintaining, or configured to maintain, fluid flow between a firstpassage in which the first end portion is anchored and a second passagein which the second end portion is anchored. The first passage may besubstantially parallel to the second passage. The intermediate portionmay be conformable to an “S” shape.

The device may have a diameter between about 1 mm and about 12 mm (e.g.,between 2 mm and 6 mm). The device may have a diameter between about 1mm and about 10 mm (e.g., between 4 mm and 8 mm). The device may have adiameter between about 6 mm and about 25 mm (e.g., between 12 mm and 15mm). The device may have a diameter between about 20 mm and about 50 mm(e.g., between 35 mm and 40 mm). The device may have a length betweenabout 25 mm and about 150 mm (e.g., between 70 mm and 110 mm). Thedevice may include filaments having a diameter between about 0.001inches and about 0.01 inches (e.g., between 0.003 inches and 0.006inches). The device may include struts having a diameter between about0.001 inches and about 0.01 inches (e.g., between 0.003 inches and 0.006inches).

In some embodiments, a device for providing or maintaining fluid flowthrough at least one passage in a human or animal body includes two endportions for anchoring the device in position and an intermediateportion that allows movement of the end portions relative to eachanother. The end portions and the intermediate portion together define apathway for fluid flow through the device.

By allowing the two end portions to move relative to each other, thedevice can respond to movement of the passage or passages in which thedevice is used. The intermediate portion may be flexible to allowrelative movement of the end portions. In some embodiments, the devicehas varying or differential flexibility along the length of the deviceor along a length of a portion of the device. Device flexibility canreduce the likelihood of device failure due to fatigue, for examplebecause the magnitude of stresses within the intermediate portion may berelatively low in comparison to stresses on a support structure (e.g.,stent) with uniform flexibility along its entire length.

The device may be configured to provide or maintain fluid flow through asingle passageway, for example an occluded blood vessel. Theintermediate portion may be capable of maintaining, or configured tomaintain, fluid flow between proximal and distal portions of theoccluded blood vessel. The intermediate portion can pass through afurther passage, for example outside the blood vessel, extending betweenthe proximal and distal portions of the blood vessel. The device may beconfigured for use as a bypass between proximal and distal portions of asingle blood vessel, for example an artery or a vein.

The device may be configured to provide fluid flow from an occludedblood passage to another passage. The passages can be interconnected bythe intermediate portion passing through a further passage extendingbetween the two passages. The device may be configured for use as ashunt between two passages, for example between an artery and a vein.

In embodiments in which the end portions can move relative to oneanother by virtue of the intermediate portion, the device may besuitable for use in applications where the end portions are anchored inseparate passages that move relative to one another. A pathway for fluidcommunication to be maintained through the device irrespective of therelative movement of the end portions, and the likelihood of fatiguefailure of the device due to cyclic movement of the end portions may below in comparison to a support structure (e.g., stent) lacking such anintermediate portion.

One or both of the end portions may be diametrically expandable toanchor the device in position. An expanded end portion may, for example,be expandable to meet with and press against the inner sidewalls of apassage to inhibit or prevent substantial sliding or rotation of the endportion within the passage, and/or to dilate the passage. Theintermediate portion may be diametrically expandable, for example todilate the fluid flow pathway.

The device may be in the form of a tube defining a lumen configured toact as a fluid flow pathway. In some embodiments, the tube may befluid-tight, so as to confine the fluid flow within the lumen of thetube. The tube may include, but is not limited to, a polymeric material,for example a biocompatible polymer such as polytetrafluoroethylene(PTFE) or polyurethane such as polycarbonate aromatic biodurablethermoplastic polyurethane elastomer (e.g., ChronoFlex C® 80A and 55Dmedical grade, available from AdvanSource Biomaterials of Wilmington,Mass.).

The device may include a supporting structure that supports the endportions. The supporting structure may support the intermediate portion,in which case the supporting structure may be flexible within theintermediate portion to allow movement of the end portions relative toeach other.

When a supporting structure is provided, the supporting structure or aportion thereof may be embedded within a wall of the tube. Alternativelyor in addition, the structure or a portion of the structure may belocated on the outside of the tube or within the lumen of the tube.

The supporting structure may include at least one mesh. For example, asingle mesh may extend along the entire length of the device. In anotherexample, each end of the device includes a mesh, in which case themeshes may stop short of the intermediate portion or may extend into theintermediate portion. When a mesh is present in the intermediateportion, the mesh may have a higher density or smaller window size(e.g., a smaller spacing between filaments and/or struts of the mesh) inthe end portions than in the intermediate portion so that the device isrelatively more flexible in the intermediate portion than in the endportions. The device may be relatively more flexible in the intermediateportion than in the end portions by way of absence of a mesh, or evenwhen including a mesh with substantially uniform or uniform density orwindow size (e.g., due to factors other than mesh density or windowsize), or by including a mesh having a non-uniform density.

At least one mesh may include biocompatible metal wire. For example, themetal wire may be stainless steel. Alternatively, or in addition, atleast one mesh may include a shape memory material, for example nitinoland/or chromium cobalt. When a shape memory material is used, at least aportion of the device may be self-expanding.

One or both end portions may include anchoring protuberances or barbscapable of and/or configured to dig into or grasp the inside sidewallsof a passage, for example to prevent or reduce slippage or othermovement of one or both of the end portions relative to the passage.

The two end portions may have different diameters, so that the devicecan be made to fit securely within a passage having variable diameter,or with one end portion in a first passage and the other end portion ina second passage, when the passages have different diameters. The devicecan be configured for a particular application and/or for a particularpatient.

In some embodiments, a method of diverting fluid flow from a firstpassage to a second passage (e.g., adjacent to the first passage)includes forming a third passage between the first and second passages,providing a device having two end portions and an intermediate portion,deforming the intermediate portion of the device to permit insertion ofthe device in the passages, and expanding the end portions against thewalls of the first and second passages so as to anchor the device in thepassages. The intermediate portion of the device may be flexed to permitinsertion of the device in the passages. The two end portions and theintermediate portion may be configured to maintain or provide fluid flowthrough the device.

One or more end portions of the device may be expanded by a ballooncatheter. Alternatively, or in addition, at least one end portion may beself-expanding, in which case the method may include providing thedevice in a retaining sleeve, and removing the retaining sleeve toenable the at least one end portion to expand.

The method may further include expanding the intermediate portion todilate the third passage, thereby forming a larger pathway for fluidflow from the first passage to the second passage.

The methods described herein may be used in many surgical procedures,and can be performed by minimally invasive (key-hole) techniques. Themethods may be particularly suitable for the treatment of coronary heartdisease, for example by providing a shunt or bypass to divert arterialblood from an occluded coronary artery to a coronary vein (e.g.,adjacent to the coronary artery) and/or by traversing an occlusion in acoronary artery by exiting the artery proximal to the occlusion,extending through subintimal tissue, external tissue, and/or a portionof a proximate vessel, and reentering the coronary artery distal to theocclusion, for peripheral vascular disease such as critical limbischemia, for example by providing a shunt or bypass to divert arterialblood from an occluded peripheral artery to a peripheral vein and/or bytraversing an occlusion in a peripheral vessel by exiting the vesselproximal to the occlusion, extending through subintimal tissue, externaltissue, and/or a portion of a proximate vessel, and reentering thevessel distal to the occlusion, and/or for non-occluded vessels, forexample by creating a shunt between a healthy artery and a healthy veinthat can be used for dialysis access.

In some embodiments, a method of treating coronary heart diseaseincludes diverting arterial blood from a coronary artery to a coronaryvein by the methods described herein. In some embodiments, a method oftreating critical limb ischemia includes diverting arterial blood from aperipheral artery to a peripheral vein by the methods described herein.

In some embodiments, a method of accessing a target vein comprisesinserting a needle into the target vein and inserting a guidewire intothe target vein through the needle.

The target vein may be the proximal tibial vein. The method may furthercomprise advancing a catheter over the second guidewire. The guidewiremay comprise an ultrasound receiving transducer. The method may furthercomprise advancing the guidewire in a direction of flow of blood in thetarget vein. The method may further comprise inserting an introducersheath into a second vein upstream of the target vein. The method mayfurther comprise inserting a second guidewire into the second vein. Thesecond guidewire may comprise an ultrasound receiving transducer. Themethod may further comprise at least one of snaring the guidewire withthe second guidewire or a snare and snaring the second guidewire withthe guidewire, and pulling the second guidewire in a direction oppositeof blood flow into the target vein. Snaring the guidewire may compriseinjecting contrast and visualizing using fluoroscopy. The method mayfurther comprise advancing a catheter over the second guidewire. Thecatheter may comprise an ultrasound receiving transducer.

In some embodiments, a device for making valves of a vessel incompetentcomprises a proximal portion, a distal portion and a longitudinal axisbetween the proximal portion and the distal portion. The distal portionmay comprise at least one blade. The at least one blade may have aretracted position in which the at least one blade is substantiallyparallel to the longitudinal axis and an expanded position in which theat least one blade is substantially non-parallel to the longitudinalaxis. The at least one blade may comprise a sharp surface facingdistally and configured to at least partially ablate a valve duringdistal advancement of the device.

The at least one blade may comprise a plurality of blades. The pluralityof blades may comprise three blades. The three blades may becircumferentially spaced by about 120 degrees. The proximal portion maycomprise a handle configured to operate the at least one blade betweenthe retracted position and the expanded position. The at least one blademay comprise shape memory material. The handle may be configured toallow the at least one blade to self-expand from the retracted positionto the expanded position. The handle may be configured to longitudinallycompress and radially expand the at least one blade from the retractedposition to the expanded position. A kit may comprise the device and avessel expansion device. The vessel expansion device may comprise atleast one of a tourniquet, a balloon, and a LeMaitre device.

In some embodiments, a method of making valves of a vessel incompetentcomprises advancing a reverse valvulotome in a direction opposite nativefluid flow in the vessel. During advancing the reverse valvulotome, atleast one blade of the reverse valvulotome at least partially ablatesthe valves.

The reverse valvulotome may comprise at least one blade. The at leastone blade may have a retracted position in which the at least one bladeis substantially parallel to the longitudinal axis and an expandedposition in which the at least one blade is substantially non-parallelto the longitudinal axis. The at least one blade may comprise a sharpsurface facing distally and configured to at least partially ablate avalve during distal advancement of the device. The at least one blademay comprise a plurality of blades. The plurality of blades may comprisethree blades. The three blades may be circumferentially spaced by about120 degrees. The method may further comprise expanding the vessel andthe valves in the vessel. Expanding the vessel and the valves in thevessel may comprise applying a tourniquet to a body part comprising thevessel. Expanding the vessel and the valves in the vessel may compriseexpanding a balloon in the vessel. Expanding the vessel and the valvesin the vessel may comprise expanding a LeMaitre device in the vessel.

In some embodiments, a method of effecting retroperfusion in a firstvessel comprises forming a fistula between the first vessel and a secondvessel and making valves in the first vessel incompetent.

The first vessel may comprise a vein and the second vessel may comprisean artery. Making the valves in the first vessel incompetent maycomprise inflating a balloon to a pressure greater than about 10atmospheres (atm) (approx. 1,013 kilopascals (kPa)) across the valves.Making the valves in the first vessel incomepetent may comprisedeploying at least one stent across the valves. Making the valves in thefirst vessel incompetent may comprise inflating a cutting balloon.Making the valves in the first vessel incompetent may compriseatherectomy. Making the valves in the first vessel incompetent maycomprise ablating the valves with ultrasound. Making the valves in thefirst vessel incompetent may comprise ablating the valves with a laser.Making the valves in the first vessel incompetent may comprise ablatingthe valves with radio frequency. Making the valves in the first vesselincompetent may comprise heating the valves. Making the valves in thefirst vessel incompetent may comprise at least one of advancing andretracting a catheter comprising a traumatic tip. Making the valves inthe first vessel incompetent may comprise expanding the vessel and thevalves in the vessel. Expanding the vessel and the valves in the vesselmay comprise applying a tourniquet to a body part comprising the vessel.Expanding the vessel and the valves in the vessel may comprise expandinga balloon in the vessel. Expanding the vessel and the valves in thevessel may comprise expanding a LeMaitre device in the vessel. Makingthe valves in the first vessel incompetent may comprise expanding thefirst vessel and the valves in the first vessel, advancing a guidewirethrough the vessel, and tracking a device over the guidewire. Expandingthe first vessel and the valves in the first vessel may compriseapplying a tourniquet to a body part comprising the first vessel.Expanding the first vessel and the valves in the first vessel maycomprise expanding a balloon in the first vessel. Expanding the firstvessel and the valves in the first vessel may comprise expanding aLeMaitre device in the vessel. Forming the fistula between the arteryand the vein may comprise accessing the vein. Accessing the vein maycomprise inserting a needle into the vein and inserting a guidewire intothe vein through the needle. The vein may be the proximal tibial vein.The method may further comprise advancing a catheter over the secondguidewire. The guidewire may comprise an ultrasound receivingtransducer. The method may further comprise advancing the guidewire in adirection of flow of blood in the vein. The method may further compriseinserting an introducer sheath into a second vein upstream of the vein.The method may further comprise inserting a second guidewire into thesecond vein. The second guidewire may comprise an ultrasound receivingtransducer. The method may further comprise at least one of snaring theguidewire with the second guidewire or a snare and snaring the secondguidewire with the guidewire, and pulling the second guidewire in adirection opposite of blood flow into the vein. Snaring the guidewiremay comprise injecting contrast and visualizing using fluoroscopy. Themethod may further comprise advancing a catheter over the secondguidewire. The catheter may comprise an ultrasound receiving transducer.Forming the fistula between the first vessel and the second vessel maycomprise inserting a launching catheter into the second vessel,inserting a target catheter into the first vessel, emitting anultrasound signal from the ultrasound emitting transducer, duringemitting the ultrasound signal and until the ultrasound signal isreceived by the ultrasound receiving transducer, at least one ofrotating the launching catheter and longitudinally moving the launchingcatheter, and after the ultrasound signal is received by the ultrasoundreceiving transducer, extending the needle from the launching catheter.The launching catheter may comprise an ultrasound emitting transducerand a needle configured to radially extend from the launching catheter.The target catheter may comprise an ultrasound receiving transducer.Extending the needle may comprise exiting the second vessel, traversinginterstitial tissue between the second vessel and the first vessel, andentering the first vessel. The ultrasound emitting transducer maycomprise a directional transducer. The needle may be configured toradially extend from the launching catheter along a path aligned with apath of the directional transducer. The ultrasound receiving transducermay comprise an omnidirectional transducer. Forming the fistula betweenthe first vessel and the second vessel may comprise identifying signalalignment peaks on a display device. Identifying the signal alignmentpeaks on the display device may comprise identifying a color indicativethat the signal alignment peaks are greater than a threshold value.Forming the fistula between the first vessel and the second vessel maycomprise identifying an audible signal indicative that signal alignmentis greater than a threshold value. Forming the fistula between the firstvessel and the second vessel may comprise inserting a launching catheterinto the second vessel. The launching catheter comprises a needleconfigured to radially extend from the launching catheter. Forming thefistula between the first vessel and the second vessel may furthercomprise inserting a target catheter comprising a target device into thefirst vessel, expanding the target device, and extending the needle fromthe launching catheter. Extending the needle may comprise exiting thesecond vessel, traversing interstitial tissue between the second vesseland the first vessel, and entering the first vessel, wherein, duringentering the first vessel, the needle punctures the target device. Thetarget device may comprise a balloon. The balloon may comprise a polymerand a mesh at least partially embedded in the polymer. Expanding thetarget device may comprise inflating the balloon. The target device maycomprise a mesh. Expanding the target device may comprise distallyadvancing a proximal portion of the mesh. Expanding the target devicemay comprise proximally retracting a distal portion of the mesh.Expanding the target device may comprise allowing the mesh toself-expand. Forming the fistula between the first vessel and the secondvessel may comprise inserting a crossing guidewire through the fistula.Forming the fistula between the first vessel and the second vessel maycomprise dilating the fistula. Dilating the fistula may compriseinflating a balloon. Forming the fistula between the first vessel andthe second vessel may comprise deploying a prosthesis. After deployingthe prosthesis, at least a first portion of the prosthesis may be in thefirst vessel and at least a second portion of the prosthesis may be inthe second vessel. Deploying the prosthesis may comprise actuating atrigger handle. The prosthesis may comprise a stent graft. The stentgraft may comprise a longitudinal portion having a frustoconicallongitudinal cross-section. Deploying the prosthesis may compriseallowing the prosthesis to self-expand. The method may further compriseexpanding the prosthesis with a balloon. The method may further compriseapplying a radiopaque clip to skin outside the skin proximate to aposition of the fistula. The method may further comprise determining adistance between the first vessel and the second vessel.

In some embodiments, a target catheter for forming a fistula comprises aproximal portion and a distal portion. The distal portion may comprisean expandable member and an ultrasound receiving transducer proximate tothe expandable member.

The expandable member may comprise a balloon. The expandable member maycomprise a mesh. The ultrasound receiving transducer may comprise anomnidirectional transducer. The ultrasound receiving transducer may beradially inward of the expandable member. The catheter may furthercomprise an inflation lumen in fluid communication with the expandablemember and the proximal portion. The catheter may further comprise apressure sensor configured to detect puncturing of the expandablemember.

In some embodiments, a kit for effecting retroperfusion in a veincomprises a valve disabling device and at least one of the groupconsisting of a launching catheter, a target catheter, a prosthesisdelivery system.

The valve disabling device may comprise at least one of a reversevalvulotome, a balloon, and a stent. The launching catheter may comprisea needle configured to radially extend from the launching catheter. Thelaunching catheter may comprise an ultrasound emitting transducer. Thekit may further comprise a guidewire. The launching catheter may beconfigured to be tracked over the guidewire. The kit may furthercomprise an artery introducer sheath. The kit may further comprise asecond guidewire. The target catheter may be configured to be trackedover the second guidewire. The target catheter may comprise anultrasound receiving transducer. The ultrasound emitting transducer maycomprise an omnidirectional transducer. The target catheter may comprisea balloon. The kit may further comprise a third guidewire. The secondguidewire may be configured to snare the third guidewire. The thirdguidewire may be configured to snare the second guidewire. The kit mayfurther comprise a vein introducer sheath. The kit may further comprisea vein access needle. The kit may further comprise an access guidewire.The kit may further comprise at least one balloon. The at least oneballoon may be configured to pre-dilate a fistula. The at least oneballoon may be configured to expand a vessel diameter. The at least oneballoon may be configured to make a valve incompetent. The at least oneballoon may be configured to apply a pressure greater than about 10 atm(approx. 1,013 kPa). The kit may further comprise a prosthesis deliverysystem. The kit may further comprise a device configured to stretch avessel. The device configured to stretch the vessel may comprise atleast one of a tourniquet, a balloon, and a LeMaitre device. The kit mayfurther comprise a computing device configured to be communicativelycoupled to at least one of the launching catheter and the targetcatheter. The computing device may comprise a laptop computer. Thecomputing device may comprise a tablet computer. The computing devicemay comprise a smartphone. The computing device may comprise a displaydevice configured to display information about relative positions of thelaunching catheter and the target catheter. The computing device maycomprise a speaker configured to emit information about relativepositions of the launching catheter and the target catheter.

In some embodiments, a method of marking a fistula point comprisesapplying a marker to skin proximate to a location of the fistula. Themarker may be visible under fluoroscopy.

The marker may comprise a clip. The marker may comprise radiopaquematerial. The fistula may be between a first vessel and a second vessel.Applying the marker may be before deploying a prosthesis in the fistula.

In some embodiments, a method of making valves of a vessel incompetentcomprises providing a reverse valvulotome. Upon advancing the reversevalvulotome in a direction opposite native fluid flow in the vessel, atleast one blade of the reverse valvulotome at least partially ablatesthe valves.

In some embodiments, a method of effecting retroperfusion in a firstvessel comprises providing a first system configured to create a fistulabetween the first vessel and a second vessel and providing a seconddevice configured to make valves in the first vessel incompetent.

In some embodiments, a method of forming a fistula in a first vesselcomprises inserting a launching catheter into a second vessel. Thelaunching catheter comprises an ultrasound emitting transducer and aneedle configured to radially extend from the launching catheter. Themethod may further comprise inserting a target catheter comprising anultrasound receiving transducer into the first vessel, emitting anultrasound signal from the ultrasound emitting transducer, and duringemitting the ultrasound signal and until the ultrasound signal may bereceived by the ultrasound receiving transducer, at least one ofrotating the launching catheter and longitudinally moving the launchingcatheter. The method may further comprise, after the ultrasound signalmay be received by the ultrasound receiving transducer, extending theneedle from the launching catheter. Extending the needle may compriseexiting the second vessel traversing interstitial tissue between thesecond vessel and the first vessel, and entering the first vessel.

The ultrasound emitting transducer may comprise a directionaltransducer. The needle may be configured to radially extend from thelaunching catheter along a path aligned with a path of the directionaltransducer. The ultrasound receiving transducer may comprise anomnidirectional transducer.

In some embodiments, a kit for effecting retroperfusion in a veincomprises a launching catheter, a target catheter, and a prosthesisdelivery system.

The launching catheter may comprise a needle configured to radiallyextend from the launching catheter. The launching catheter may comprisean ultrasound emitting transducer. The target catheter may comprise anultrasound receiving transducer. The ultrasound emitting transducer maycomprise an omnidirectional transducer.

The methods summarized above and set forth in further detail belowdescribe certain actions taken by a practitioner; however, it should beunderstood that they can also include the instruction of those actionsby another party. Thus, actions such as “making valves in the firstvessel incompetent” include “instructing making valves in the firstvessel incompetent.”

For purposes of summarizing the invention and the advantages that may beachieved, certain objects and advantages are described herein. Notnecessarily all such objects or advantages need to be achieved inaccordance with any particular embodiment. In some embodiments, theinvention may be embodied or carried out in a manner that can achieve oroptimize one advantage or a group of advantages without necessarilyachieving other objects or advantages.

All of these embodiments are intended to be within the scope of theinvention herein disclosed. These and other embodiments will be apparentfrom the following detailed description having reference to the attachedfigures, the invention not being limited to any particular disclosedembodiment(s). Optional and/or preferred features described withreference to some embodiments may be combined with and incorporated intoother embodiments. All references cited herein, including patents andpatent applications, are incorporated by reference in their entirety.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentdisclosure are described with reference to the drawings of certainembodiments, which are intended to illustrate certain embodiments andnot to limit the invention, in which like reference numerals are usedfor like features, and in which:

FIG. 1 schematically illustrates an example embodiment of a launchingdevice directing a signal from a first body cavity to a target device ina second body cavity.

FIG. 2 is a cross-sectional representation along the dotted line B-B ofFIG. 1.

FIG. 3 schematically illustrates an example embodiment of a launchingdevice.

FIG. 4 schematically illustrates an example embodiment of a targetdevice.

FIG. 5 schematically illustrates another example embodiment of alaunching device.

FIG. 6 schematically illustrates an example embodiment of centeringdevices for launching and/or target devices.

FIG. 7 schematically illustrates a prosthesis in place following aprocedure such as arterial-venous arterialization.

FIG. 8 is a side perspective view of an example embodiment of a devicefor providing fluid flow.

FIG. 9 shows the device of FIG. 8 in use as a shunt between two bloodvessels.

FIG. 10 is a side perspective view of another example embodiment of adevice for providing fluid flow.

FIG. 11 is a side perspective view of still another example embodimentof a device for providing fluid flow.

FIG. 12 is a side perspective view of yet another example embodiment ofa device for providing fluid flow.

FIG. 13 is a side perspective view of yet still another exampleembodiment of a device for providing fluid flow.

FIG. 14A is a schematic side cross-sectional view of an exampleembodiment of an ultrasound launching catheter.

FIG. 14B is an expanded schematic side cross-sectional view of a distalportion of the ultrasound launching catheter of FIG. 14A within thecircle 14B.

FIG. 15A is a schematic side elevational view of an example embodimentof an ultrasound target catheter.

FIG. 15B is an expanded schematic side cross-sectional view of theultrasound target catheter of FIG. 15A within the circle 15B.

FIG. 15C is an expanded schematic side cross-sectional view of theultrasound target catheter of FIG. 15A within the circle 15C.

FIG. 16 is an example embodiment of a graph for detecting catheteralignment.

FIG. 17 is a schematic side elevational view of an example embodiment ofa prosthesis delivery system.

FIG. 18 is a schematic side elevational view of an example embodiment ofa prosthesis.

FIG. 19 is a schematic side elevational view of another exampleembodiment of a prosthesis.

FIGS. 20A-20H schematically illustrate an example embodiment of a methodfor effecting retroperfusion.

FIG. 21 is a schematic perspective view of an example embodiment of anultrasound receiving transducer.

FIG. 22 is a schematic cross-sectional view of another exampleembodiment of an ultrasound receiving transducer.

FIG. 23A is a schematic perspective view of an example embodiment of avalvulotome.

FIG. 23B is a schematic perspective view of an example embodiment of areverse valvulotome.

FIG. 24 is a schematic perspective view of an example embodiment of aLeMaitre device.

DETAILED DESCRIPTION

Although certain embodiments and examples are described below, theinvention extends beyond the specifically disclosed embodiments and/oruses and obvious modifications and equivalents thereof. The scope of theinvention herein disclosed should not be limited by any particularembodiment(s) described below.

Minimally invasive surgery could provide a means for treating a broaderrange of patients, including those currently excluded from standardsurgical techniques. One such procedure is percutaneous in situ coronaryvenous arterialization (PICVA), which is a catheter-based coronarybypass procedure in which the occlusion in the diseased artery is“bypassed” by creation of a channel between the coronary artery and theadjacent coronary vein. In this way, the arterial blood is diverted intothe venous system and can perfuse the cardiac tissue in a retrogrademanner (retroperfusion) and restores blood supply to ischemic tissue.Some example devices and methods for performing procedures like PICVAare described in PCT Pub. No. WO 99/049793 and U.S. Patent Pub. No.2004/0133225, which are hereby incorporated by reference in theirentirety.

Successfully performing a minimally invasive procedure of divertingblood flow from the coronary artery to the adjacent vein heretofore hashad a low success rate, most often due to inability to properly targetthe vein from the artery. Without the proper systems and methods, suchprocedures (e.g., attempting to target the vein by combination of X-rayfluoroscopy and an imaging ultrasound probe located on the distal tip ofthe catheter e.g., as described in U.S. Patent Pub. No. 2004/0133225)are often doomed to failure before even starting. Indeed, such anarrangement can be difficult to navigate, and localization of theadjacent vein can require considerable skill on the part of theclinician. Improvements in the systems and methods for targeting, suchas those using the catheters described herein, can enable proceduressuch as PICVA and transvascular surgery in general. Without suchimprovements, such percutaneous techniques will remain peripheral toconventional surgical open-heart and other types of bypass operations.

The present application, according to several embodiments, describesmethods and systems usable in minimally invasive surgical procedures,which can reduce performance of conventional surgery to treat conditionssuch as coronary heart disease and critical limb ischemia. For example,patients who might otherwise be unable to receive surgery such ascoronary bypass surgery or peripheral arterial bypass surgery can betreated, and the amount of surgical trauma, the risk of infection,and/or the time to recovery may be reduced or significantly reduced incomparison to conventional surgery.

FIG. 1 schematically illustrates an example embodiment of a launchingdevice 10 directing a signal from a first body cavity 30 to a targetdevice 20 in a second body cavity 35. The launching device 10 comprisesa signal transmitter 12. The launching device 10 may comprise, forexample, a catheter including an elongate flexible rod-like portion anda tip portion, and may provides a conduit for administering therapywithin the body of a patient. The launching device 10 may be suitablefor location and movement through a first cavity or vessel 30 (e.g.,heart chamber, coronary artery, coronary vein, peripheral artery,peripheral vein) within a patient's body. The elongate portion of thelaunching device 10 comprises an outer sheath 11 that encloses a space,defining a lumen 13. The space within the lumen 13 may be suitablypartitioned or subdivided as necessary so as to define channels foradministering therapy, controlling the positioning of the launchingdevice 10, etc. Such subdivision may, for example, be achieved eitherlongitudinally or concentrically in an axial fashion.

The launching device 10 comprises a signal transducer 12. The signaltransducer 12 is configured to provide or emit a signal 40 that isdirected outwards from the launching device 10. In the embodiment shownin FIG. 1, the signal 40 is directed radially outward from the launchingdevice 10 in a direction that is perpendicular to the longitudinal axisof the launching device 10. As mentioned in greater detail below, insome embodiments, the direction of the signal 40 need not beperpendicular and can be directed at an angle to the longitudinal axisof the launching device 10. The signal transducer 12 may thereby form atleast a portion of a signal generating means.

The signal transducer 12 is connected to signal transmitter 50. Thesignal transmitter 50 can be suitably selected from ultrasound orappropriate electromagnetic sources such as a laser, microwaveradiation, radio waves, etc. In some embodiments, as described infurther detail below, the signal transmitter 50 is configured togenerate an ultrasound signal, which is relayed to the signal transducer12, which in turn directs the signal 40 out of the first body cavity 30into the surrounding tissue.

A target device 20 is located within an adjacent second body cavity orvessel 32 (e.g., heart chamber, coronary artery, coronary vein,peripheral artery, peripheral vein) within a patient's body. The firstand second body cavities 30, 32 are separated by intervening tissue 34,sometimes referred to as interstitial tissue or a septum. The first andsecond body cavities 30, 32 are located next to each other in a parallelfashion for at least a portion of their respective lengths. For example,many of the veins and arteries of the body are known to run in parallelwith each other for at least a portion of their overall length.

The target device 20 can assume a similar arrangement to that of thelaunching device 10. For example, the target device 20 can comprise acatheter including an elongate flexible rod-like portion and a tipportion. For another example, fine movement and positioning of thetarget device 20 within the body cavity 32 can be achieved. For yetanother example, the target device 20 may comprise an outer sheath 21that encloses a space, defining a lumen 23. The lumen 23 can be suitablypartitioned, for example as with the launching device 10.

The target device 20 comprises a receiving transducer 22 configured toreceive the signal 40 from the transducer 12 of the launching device 10.The receiving transducer 22 makes up at least a portion of a signaldetection means. In use, when the receiving transducer 22 receives thesignal 40 transmitted from the signal transducer 12, the receivingtransducer 22 transmits the received signal to a signal detector 60. Thesignal detector 60 is configured to provide an output reading to theuser of the system, for example via an output display 61. The outputdisplay 61 may be a visual display, an audio display (e.g., beeping oremitting some other sound upon receipt of a signal), etc.

In this way, the transmission and detection of the directed signal 40can allow for the navigation and positioning of the launching device 10relative to the target device 20. In use, the launching device 10 andthe target device 20 can be maneuvered by the user of the system untilthe output display 61 indicates that signal 40 is being received by thetarget device 40.

In some embodiments, the signal 40 comprises or is an ultrasound signal.The signal 40 is directional and is emitted by the signal transducer 12in the shape of a narrow cone or arc (e.g., with the width of the signalband increasing as the distance from the signal transducer 12increases). As such, the precision of alignment between the launchingdevice 10 and the target device 20 depends not only upon signaldetection, but also upon the distance between the two devices, as thesignal beam width is greater at greater distances. This level of erroris referred to as “positional uncertainty.” A certain level of tolerancecan exist for positional uncertainty; however, if therapy is to bedirected with precision, the amount of uncertainty should be reduced orminimized. For example, if the diameter d of the signal transducer 12 is1 mm and the frequency of the ultrasound signal is 30 MHz, then thepositional uncertainty x (e.g., the margin of error on either side of acenter line) is 1 mm at a perpendicular separation of 5 mm between thelaunching device 10 and the target device 20. For clinical applications,the positional uncertainty generally should not exceed around ±5 mm (fora total signal beam width of 10 mm at the point of reception). In someembodiments, the positional uncertainty is between about ±0.01 mm andabout ±4.50 mm or between about ±0.1 mm and about ±2 mm. In someembodiments, the positional uncertainty does not exceed about ±1 mm.

The strength of the signal 40 can be a factor in detection, and signalstrength generally diminishes as the distance between the launchingdevice 10 and the target device 20 increases. This distance is in partdetermined by the amount of intervening tissue 34 between the devices10, 20. By way of example, if the signal 40 is an ultrasound signal,significant deterioration of signal can be expected when the launchingdevice 10 and the target device 20 a separated by more than about 20 mmof solid tissue (e.g., the intervening tissue 34). The density of theintervening tissue 34 may also have an effect upon the deterioration ofsignal 40 over distance (e.g., denser tissue deteriorating the signalmore than less dense tissue).

The frequency of the ultrasound signal may also affect the thickness ofthe signal transducer, which for a standard ultrasound ceramictransducer (e.g., a piezoelectric transducer (PZT)) is 0.075 mm at 30MHz.

FIG. 2 is a cross-sectional representation along the dotted line B-B ofFIG. 1. The correct orientation of the launching device relative to thetarget device can be a factor in detection, as the line of orientation41 can determine where the therapy is to be applied. The clinical needfor precisional placing of therapy in a patient may function better ifthe directional signal 40 is linked to the means for delivering therapy(e.g., being parallel and longitudinally offset). For example, in thisway the user of the system can administer therapy to the correctlocation by ensuring that the launching device 10 and the target device20 are correctly positioned via transmission and reception of the signal40. The orientation line 41 in FIG. 2 denotes not only the direction ofsignal travel but also the path along which therapy can be administeredto the patient.

FIG. 3 schematically illustrates an example embodiment of a launchingdevice 10. The launching device 10 comprises a signal transducer 120that is oriented at an oblique angle relative to the longitudinal axisof the launching device 10. The signal 40 is transmitted at an anglethat is in the direction of travel (e.g., forward travel, transversetravel) of the launching device 10 as the launching device enters a bodycavity 30 (FIGS. 1 and 2). In some embodiments, the beam angle is aboutperpendicular to the longitudinal axis of the launching device 10. Insome embodiments, the beam angle is between about 20° and about 60° tothe perpendicular, between about 30° and about 50° to the perpendicular,or about 45° to the perpendicular, when 0° corresponds to thelongitudinal axis of the launching device 10 in the direction of travel.

The launching device 10 comprises a hollow needle or cannula 17, whichis an example means for administering therapy. During travel of thelaunching device 10, the hollow needle 17 is located in an undeployed orretracted state within the lumen 13 of launching device 10. The hollowneedle 17 may be deployed/extended from the launching device 10 via anaperture 16 in the outer sheath 11 at a time deemed appropriate by theuser (e.g., upon detection of the signal 40 by the target device 20).The aperture 16 can allow fluid communication between the lumen 13 andthe body cavity 30 (FIG. 1). As illustrated by the example embodiment ofFIG. 3, the hollow needle 17 may travel along a path that is parallel tothe direction of the signal 40. The hollow needle 17 may be used topierce the intervening tissue 34 (FIG. 1). In some embodiments, thehollow needle 17 makes a transit across the entirety of the interveningtissue 34, and in doing so allows the launching device 10 to access thesecond body cavity 32 (FIG. 2). If desired, the pathway made by thehollow needle 17 through the intervening tissue 34 can be subsequentlywidened to allow fluid communication between the first body cavity 30and the second body cavity 32.

Therapeutic means suitable for use in several embodiments can comprise,for example, devices and/or instruments selected from the groupconsisting of a cannula, a laser, a radiation-emitting device, a probe,a drill, a blade, a wire, a needle, appropriate combinations thereof,and the like.

In some embodiments, the hollow needle 17 comprises a sensor 19, whichmay assist in further determining positional information of the tip ofthe hollow needle 17 relative to the launching device 10. In someembodiments, the sensor 19 is configured to detect changes inhydrostatic pressure. Other sensors that are suitable for use in thesystems and methods described herein can include temperature sensors,oxygenation sensors, and/or color sensors.

Optionally, the hollow needle 17 can comprise an additional signaltransducer 122. In the embodiment shown in FIG. 3, the signal transducer122 is located near the tip of the hollow needle 17 on the end of aguidewire 14. The signal transducer 122 can also or alternativelylocated on the hollow needle 17 if desired. In use, the signaltransducer 122 is driven with a short transmit pulse that produces adirectional signal or a non-directional signal pulse. The signal pulsecan be detected by the receiving transducer 22 mounted on the targetdevice 20. The distance from the guidewire 14 or hollow needle 17 to thereceiving transducer 22 and hence the target device 20 can be at leastpartially determined time based on the delay between the transmission ofthe signal pulse from the signal transducer 122 and receipt of thesignal pulse on the receiving transducer 22.

FIG. 4 schematically illustrates an example embodiment of a targetdevice 20. In the embodiment shown in FIG. 4, the target device 20 islocated within a body cavity 32. As mentioned above, the target device20 comprises a receiving transducer 22 for receiving the signal 40. Thereceiving transducer 22 can be unidirectional (e.g., capable ofreceiving or configured to receive a signal from one direction only) oromnidirectional (e.g., capable of receiving or configured to receive asignal from any direction). Arrow A shows the reversed direction ofblood flow after an arterial-venous arterialization (also called PICVA)has been effected. The target device 20 comprises an omnidirectionalultrasound signal receiving transducer 60. An optional reflecting cone601 can direct the signal 40 onto a disc-shaped receiving transducer 60.An acoustically transparent window 602 can separate the reflecting cone601 from the receiving transducer 60. In some embodiments, anomnidirectional ultrasound signal receiving transducer can be obtainedby locating a cylinder of a flexible piezoelectric material such aspolyvinyldifluoride (PVDF) around the outer sheath of the target device20. In such a way, the cylinder can act in a similar or equivalentmanner to the receiving transducer 60.

In the embodiment illustrated in FIG. 4, the target device 20 comprisesan optional channel 25 for administering an agent, such as a therapeuticagent, to a patient. In some embodiments, the channel 25 functions as aconduit to allow application of a blocking material 251 that serves toat least partially obstruct or occlude the body cavity 32. The blockingmaterial 251 can be suitably selected from a gel-based substance. Theblocking material 251 can also or alternatively include embolizationmembers (e.g., balloons, self-expanding stents, etc.). The placement ofthe blocking material 251 can be directed by movement of the targetdevice 20. The presence of a guide member 24 within the lumen 23 of thetarget device 20 can allow the user to precisely manipulate the positionof the target device 20 as desired.

Referring again to FIG. 2, the launching device 10 comprises a signaltransducer 12 that may optionally be oriented so that the signal 40 istransmitted at an angle other than perpendicular to the signaltransducer 12. FIG. 5 schematically illustrates another exampleembodiment of a launching device 10. In some embodiments, for examplethe launching device 10 shown in FIG. 5, the signal transducer is in theform of a signal transducer array 123. The signal transducer array 123comprises a plurality of signal transducer elements 124, which can beoriented collectively to at least partially define a signal beam widthand angle relative to the launching device 10. Smaller size of theelements 124 can allow the signal transducer 123 to not occupy asignificant proportion the lumen 13 of the launching device 10.

The embodiment shown in FIG. 5 may be useful for ultrasound beam-formingsignaling. FIG. 5 shows an array of signal transducer elements 124 thatare separately connected to a transmitter 50 via delays 51, which allowsthe signals to each element 124 to be delayed relative to each other.The delays can provide or ensure that the ultrasound wavefronts fromeach element 124 are aligned to produce a beam of ultrasound 40 at thedesired angle. In some embodiments, for example in which the signal 40comprises visible light, an array of LEDs can also or alternatively beused.

FIG. 6 schematically illustrates an example embodiment of centeringdevices for launching and/or target devices 10, 20. To assist in theprocess of alignment between the launching device 10 in the first bodycavity 30 and the target device 20 in the second body cavity 32, one orboth of the devices 10, 20 may comprise means for centering therespective devices within their body cavities.

In some embodiments, the centering means comprises an inflatable bladderor balloon 111 that is located in the lumen 13, 23 when in an undeployedstate and, when the device 10, 20 reaches the desired location withinthe patient, can be inflated. The balloon 111 can be disposed on anouter surface of the outer sheath 11, 21. The balloon 111 can be annularin shape such that it at least partially surrounds the device 10, 20 ina toroidal or doughnut-like fashion. The balloon 111 can be arrangedsuch that it inflates on only one side or only on two opposite sides ofthe device 10, 20. As illustrated in FIG. 6, the balloon 111 is deployedon one side of the launching device 10.

In some embodiments, the centering means comprises one or more loopstructures 112 located either in the lumen 13, 23 or within recessesmade in the outer sheath 11, 21 when in an undeployed or retractedstate. When the device 10, 20 reaches the desired location within thepatient, the one or more loop structures 112 can be expanded radiallyoutwardly from the device 10, 20, thereby centering the device 10, 20within the body cavity 30, 32. Outward expansion of the loop structures112 can be suitably effected by compression of a length of wire, forexample, such that it bows outwardly from the outer sheath 11, 21. Acentering device that adopts this conformation may comprise a pluralityof compressible lengths of wire or other suitable flexible materialarranged in parallel at radially spaced intervals around the peripheryof the outer sheath 11, 21. Compression of the plurality of wires can beinduced by way of a sliding member (not shown) located proximally and/ordistally near to the ends of the plurality of wires. The sliding memberis capable of translational movement along the longitudinal axis of thedevice 10, 20. As illustrated in FIG. 6, the target device 20 comprisesfully deployed centering means 112 that has allowed the target device 20to be centered within the body cavity 32.

Other possible means for centering the devices 10, 20 within the bodycavities 30, 32 include, but are not limited to, expandableChinese-lantern type devices, reversibly expandable stents, coils,helices, retractable probes or legs, combinations thereof, and the like.

In some embodiments, the centering means or other means (e.g., balloons,metal stand-offs having differing lengths, etc.) can be used to orientthe devices 10, 20 within the body cavities 30, 32 other than in thecenter or substantially the center of the body cavities. For example,the device 10 may be oriented proximate to the wall of the body cavity30 where the needle 17 will exit the body cavity 30, which can, forexample, provide a shorter ultrasound signal path and/or reduce errordue to the needle 17 traversing intraluminal space. For another example,the device 10 may be oriented proximate to the wall of the body cavity30 opposite the wall of the body cavity 30 where the needle 17 will exitthe body cavity 30, which can, for example, provide a firm surface forthe needle 17 to push against. For yet another example, the device 20may be oriented proximate to the wall of the body cavity 32 where theneedle 17 will enter the body cavity 32, which can, for example, providea shorter ultrasound signal path. Other device orientations that areneither centered nor proximate to a vessel wall are also possible (e.g.,some fraction of the diameter away from the wall and/or the center ofthe lumen, such as ½, ⅓, ¼, etc.).

EXAMPLE

The methods and systems described herein demonstrate particular utilityin cardiovascular surgery according to several embodiments. Certainaspects are further illustrated by the following non-limiting example,in which the system is used by a clinician to perform the procedure ofarterial-venous connection (PICVA) so as to enable retroperfusion ofcardiac tissue following occlusion of a coronary artery.

The launching catheter 10 is inserted into the occluded coronary arteryby standard keyhole surgical techniques (e.g., tracking over aguidewire, tracking through a guide catheter). The target catheter 20 isinserted into the coronary vein that runs parallel to the coronaryartery by standard keyhole surgical techniques (e.g., tracking over aguidewire, tracking through a guide catheter). The coronary vein is notoccluded and, therefore, provides an alternative channel for blood flowto the cardiac muscle, effectively allowing the occlusion in thecoronary artery to be bypassed.

The launching catheter 10 comprises a PZT ultrasound transducer 12(e.g., available from CTS Piezoelectric Products of Albuquerque, N.Mex.) that is oriented such that a directional ultrasound beam istransmitted in this example at a 45° angle (relative to the longitudinalaxis of the launching device), preferably in the direction of blood flowin the artery 30, although other angles including about 90° are alsopossible. The ultrasound transducer 12 is activated, and in this examplea 30 MHz directional ultrasound signal 40 is transmitted from thelaunching catheter 10, although other frequencies are also possible. Thetarget catheter 20 comprises an omnidirectional ultrasound receivingtransducer 60. To assist with localization of both the launchingcatheter 10 and the target catheter 20, both catheters 10, 20 comprisecentering or orienting means, in this example in the form of an annularinflatable balloon 111, although other or absence of centering ororienting means are also possible. The centering means 111 on thelaunching catheter 10 is deployed by the clinician when the launchingcatheter 10 is deemed to be in an appropriate location close to the siteof the occlusion within the coronary artery 30. This may be determinedvia standard fluoroscopic imaging techniques and/or upon physicalresistance. The target catheter 20 is then moved within the adjacentcoronary vein 32 until the directed ultrasound signal 40 is detected bythe signal receiving transducer 60. To enable more precise alignmentbetween the launching catheter 10 and the target catheter 20, thecentering means 111 on the target catheter 20 can be deployed eitherbefore or after the signal 40 is detected.

Upon reception of the transmitted signal 40, the clinician can becertain that the launching catheter 10 and the target catheter 20 arecorrectly located, both rotationally and longitudinally, within theirrespective blood vessels 30, 32 to allow for the arterial-venousconnection procedure to commence. The target catheter 20 may be used toblock blood flow within the coronary vein 32 via administration of a gelblocking material 251 though a channel 25 in the target catheter 20. Theblocking material 251 may be administered at a position in the coronaryvein 32 that is downstream in terms of the venous blood flow relative tothe location of the receiving signal transducer 60.

The clinician may then initiate arterial-venous connection by deployinga hollow needle 17 from the launching catheter 10 substantially along apath that is parallel and close to the path taken by the ultrasoundsignal 40 though the intervening tissue 34 between the coronary artery30 and the coronary vein 32, or the hollow needle 17 may traverse a paththat intercepts the path of the ultrasound signal at a point within thecoronary vein 32. The hollow needle 17 optionally comprises a sensor 19near its tip that is configured to detect changes in hydrostaticpressure or Doppler flow such that the user can monitor the transitionfrom arterial pressure to venous pressure as the hollow needle 17 passesbetween the two vessels 30, 32. The hollow needle 17 optionallycomprises a guidewire 14 in a bore or lumen of the hollow needle 17during deployment. Once the hollow needle 17 and guidewire 14 havetraversed the intervening tissue 34, the hollow needle 17 may beretracted back into the lumen 13 of the launching catheter 10, leavingthe guidewire 14 in place. In some embodiments, once the hollow needle17 has traversed the intervening tissue 34, the user can separately passthe guidewire 14 through the bore or lumen of the hollow needle 17 andthen retract the needle 17 into the launching catheter 10.

The clinician withdraws the launching catheter 10 from the patient,leaving the guidewire 14 in place. A further catheter device is thenslid along the guidewire 14. FIG. 7 schematically illustrates aprosthesis 26 such as an expandable stent 26 in place following aprocedure such as arterial-venous arterialization. Further detail aboutpossible prostheses including stents and stent-grafts are providedbelow. The stent 26 may be deployed to widen the perforation in theintervening tissue 34 between the coronary artery 30 and the coronaryvein 32, in which the interrupted arrow A shows the direction of bloodflow through the stent 26 between the first and second body cavities 30,32 (e.g., arterial blood is thereby diverted into the venous system andis enabled to retroperfuse the cardiac muscle tissue). The stent 26 canblock flow upwards in the cavity 32, forcing blood flow in the cavity 32to be in the same direction as blood flow in the cavity 30. Graftmaterial of the stent 26 can form a fluid-tight lumen between the cavity30 and the cavity 32. The target catheter 20 is withdrawn from thepatient, leaving the blocking material 251 in position. Optionally, afurther block or suture may be inserted into the coronary vein toinhibit or prevent reversal of arterial blood flow, as described infurther detail herein.

Whilst the specific example described above is with respect tocardiovascular surgery, the methods and systems described herein couldhave far reaching applications in other forms of surgery. For example,any surgery involving the need to direct therapy from one body cavity(e.g., for treatment of peripheral artery disease) towards anotheradjacent body cavity could be considered. As such, applications in thefields of neurosurgery, urology, and general vascular surgery are alsopossible. The type of therapy need not be restricted to formation ofchannels between body cavities. For instance, the methods and systemsdescribed herein may also be used in directing techniques such ascatheter ablation, non-contact mapping of heart chambers, the deliveryof medicaments to precise areas of the body, and the like.

Certain techniques for effectively bypassing an occlusion in an arteryby percutaneous surgery are described above. These techniques includecreating a channel or passage between a first passage, such as an arteryupstream of an occlusion, a vein, or a heart chamber, and a secondpassage, such as an artery, vein, or heart chamber, proximate to thefirst passage to interconnect the first and second passages by a thirdpassage. Fluid such as blood may be diverted from the first passage intothe second passage by way of the interconnecting third passage. Inembodiments in which the first passage includes an artery and the secondpassage includes a vein, the arterial blood can perfuse into tissue in aretrograde manner (retroperfusion).

As described above, an interconnecting passage between first and secondbody passages can be created by, for example, deploying a needleoutwards from a first catheter located within the first passage, so thatthe needle traverses the interstitial tissue or septum between the firstand second passages. A second catheter may be located in the secondpassage, so as to provide a target device which receives a signal, forexample an ultrasound signal, transmitted from the first catheter. Bymonitoring the received signal, the position of the first catheter withrespect to the second catheter can be determined so as to ensure thatthe needle is deployed in the correct position and orientation to createa passage for fluid flow between the first and second passages.

In order to provide or maintain the flow of blood thorough theinterconnecting passage or channel, a structure including a lumen may beinserted in the passage to support the interstitial tissue and/or toinhibit or prevent the passage from closing. The tube may, for example,include a stent expanded in the channel using a balloon catheter orself-expansion, as described herein. A catheter to deliver thestructure, for example a balloon catheter or catheter that allowsself-expansion, may be guided to the channel by a guidewire deployed inthe passage by the first catheter.

Passages such as arteries, veins, and heart chambers can pulsate as theheart beats, for example due to movement of heart walls, peripherallimbs, and/or fluctuations in pressure within the passages themselves.This pulsation can cause movement of the passages relative to eachanother, which can impose stress on a structure within aninterconnecting passage therebetween. This stress may be large incomparison to stress experienced by a structure within a single passage.Stress can lead to premature failure of the structure, for example byfatigue failure of the stent struts. Failure of the structure may resultin injury to the interstitial tissue and/or occlusion of theinterconnecting passage, which could lead to significant complicationsor complete failure of the therapy.

FIG. 8 illustrates a device or implant or prosthetic 100 for providingor maintaining fluid flow through at least one passage. The device 100includes a first or proximal end portion 102, a second or distal endportion 104, and an intermediate portion 106 between the proximal endportion 102 and the distal end portion 104. The device includes a boreor lumen 110 for passage of fluid through the device 100. The device100, for example at least the intermediate portion 106 of the device100, includes a flexible polymer tube 108. The flexible polymer tube 108may at least partially define the lumen 110.

The device 100 includes a support structure (e.g., at least one stent)including a mesh 112 and a mesh 114. In some embodiments, at least aportion of the mesh 112 is embedded in the outside wall of the tube 108proximate to the proximal end portion 102 of the device 100. In someembodiments, at least a portion of the mesh 114, for example a wire or astrut, is embedded in the outside wall of the tube 108 proximate to thedistal end portion 104 of the device 100. The meshes 112, 114 mayinclude biocompatible metal such as stainless steel and/or shape memorymaterial such as nitinol or chromium cobalt.

The wire meshes 112, 114 can stiffen the end portions 102, 104,respectively. In some embodiments in which the intermediate portion 106does not include a mesh, the intermediate portion 106 may be relativelyflexible in comparison to the end portions 102, 104, and/or the endportions 102, 104 may have a relatively high radial stiffness.

In some embodiments, the end portions 102, 104 of the device 100 arediametrically expandable. For example, the wire meshes 112, 114 may havea smaller diameter after formation or manufacture than the passages, forexample blood vessels, into which the device 100 will be deployed. Whenthe device 100 is in position in the passages, the end portions 102, 104can be expanded or deformed outwardly so that the respective diametersof the end portions 102, 104 increase, for example to abut the interiorsidewalls of the passages. The end portions 102, 104 are configured tomaintain the expanded diameter indefinitely, for example by plasticdeformation of the material (e.g., wires, struts) of the meshes 112, 114and/or by provision of a locking mechanism arranged to mechanically lockthe meshes 112, 114 in the expanded position. The intermediate portion106 of the device 100 may be diametrically expandable, for example byway of plastic deformation of the tube 108.

FIG. 9 shows the device 100 of FIG. 8 deployed to provide a fluid flowpath between a first passage 116 and a second passage 118. The passages116, 118 may include coronary blood vessels, for example a coronaryartery 116 and a coronary vein 118, or vice versa. The passages 116, 118may include peripheral blood vessels (e.g., blood vessels in limbs), forexample a femoral or other peripheral artery 116 and a femoral or otherperipheral vein 118, or vice versa. The end portions 102, 104 and theintermediate portion 106 of the device 100 have been expanded to meetwith and push against the inner walls of the passages 116, 118. Thedistal end portion 104 of the device 100 is located within the secondpassage 118, and the proximal end portion 102 of the device 100 islocated within the first passage 116. The intermediate portion 106extends through an opening or interconnecting passage 130 surgicallyformed between the passages 116, 118.

The expanded end portions 102, 104 of the device 100 are resilient, andimpart an outward radial force on the inner walls of the passages 116,118. By virtue of the radial stiffness of the end portions 102, 104 ofthe device 100, the end portions 102, 104 are held or anchored in placewithin the respective passages 116, 118. Slippage of the device 100within the passages 116, 118 is thereby prevented or reduced. In thisway, the end portions 102, 104 of the device 100 can anchor or fix thedevice 100 in position, in use, while providing or maintaining fluidflow through the lumen 110 of the tube 108 (FIG. 8). In this way, thedevice 100 can act as a shunt between the first passage 116 and thesecond passage 118.

The intermediate portion 106 of the device 100 may be flexible, forexample allowing the intermediate portion 106 to form an ‘S’ shapeformed by the combination of the first passage 116, the second passage118, and the interconnecting passage 130 (FIG. 9). The flexibleintermediate portion 106 can allow the end portions 102, 104 of thedevice 100 to move with respect to one another in response to relativemovement of the passages 116, 118.

In embodiments in which the intermediate portion 106 does not include awire mesh but includes the flexible polymer material of the tube 108,the intermediate portion 106 may not be susceptible to damage due tomesh fatigue, for example upon cyclic or other stress imparted byrelative movement of the passages 116, 118.

The intermediate portion 106 of the device 100 has sufficient resilienceto maintain dilatation of the interconnecting passage 130, so that theinterconnecting passage 130 remains open to provide or maintain a pathfor blood flow from the artery 116 to the vein 118 by way of the lumen110 of the tube 108 (FIG. 8). Blood flow from the artery 116 to the vein118, by way of the interconnecting passage 130, may thereby be providedor maintained through the lumen 110 of the tube 108. The device 100 atleast partially supports the artery 116, the vein 118, and theinterconnecting passage 130 to provide a pathway for fluid communicationthrough the device 100.

The proximal end portion 102 and the distal end portion 104 of thedevice 100 are arranged so that, when the device 100 is deployed withthe distal end portion 104 in a vein 118 and the proximal end portion102 in an artery 116, for example as shown in FIG. 9, the diameter ofthe expanded distal end portion 104 is sufficient to hold the distal endportion 104 within the vein 118, and the diameter of the expandedproximal end portion 102 is sufficient to hold the proximal end portion102 within the artery 116. The diameter of the proximal end portion 102may therefore differ from the diameter of the distal end portion 104. Byselecting appropriate diameters for the end portions 102, 104 and theintermediate portion 106, the device 100 can be tailored to a certainanatomy and/or the anatomy of an individual patient.

An example procedure for positioning the device 100 of FIG. 8 to providea shunt between an occluded artery 116 and a vein 118 (e.g., a coronaryartery 116 and a coronary vein 118, or a peripheral artery 116 and aperipheral vein 118) to achieve retroperfusion of arterial blood, forexample as shown in FIG. 9, will now be described.

A catheter may be inserted into the patient's arterial system by way ofa small aperture cut, usually in the patient's groin area. The catheteris fed to the artery 116 and guided to a position upstream of the siteof the occlusion, for example at a site proximate and parallel orsubstantially parallel to a vein 118. A hollow needle is deployed fromthe catheter, through the wall of the artery 116, through theinterstitial tissue 132 that separates the artery 116 and vein 118, andthrough the wall of the vein 118. The path of the needle creates aninterconnecting passage or opening 130, which allows blood to flowbetween the artery 116 and the vein 118. Deployment of the needle may beguided by a transmitter (e.g., a directional ultrasound transmitter)coupled to a catheter in the artery 116 and a receiver (e.g., anomnidirectional ultrasound receiver) coupled to a catheter in the vein118, or vice versa, for example as described herein and in U.S. patentapplication Ser. No. 11/662,128. Other methods of forming the opening130 are also possible (e.g., with or without directional ultrasoundguidance, with other types of guidance such as described herein, fromvein to artery, etc.).

Before the needle is withdrawn from the passage 130, a guidewire (e.g.,as described with respect to the guidewire 14 of FIG. 3) is insertedthrough the hollow needle and into the vein 118. The needle is thenretracted, leaving the guidewire in place in the artery 116, the passage130, and the vein 118. The catheter carrying the needle can then bewithdrawn from the patient's body. The guidewire can be used to guidefurther catheters to the interconnecting passage 130 between the artery116 and the vein 118.

A catheter carrying the device 100 in a non-expanded state is advancedtowards the interconnecting passage 130, guided by the guidewire, forexample by a rapid exchange lumen or through the lumen 110. The cathetermay include, for example, a balloon catheter configured to expand atleast a portion of the device 100 and/or a catheter configured to allowself-expansion of at least a portion of the device 100. The distal endportion 104 of the device 100 is passed through the interconnectingpassage 130 and into the vein 118, leaving the proximal end portion 102in the artery 116. The intermediate portion 106 of the device 100 is atleast partially in the passage 130, and is at least partially within theartery 116 and the vein 118. The intermediate portion 106 flexes toadopt a curved or “S”-shaped formation, depending on the anatomy of thesite. Adoption of such curvature may conform the shape of anintermediate portion 106 extending through the interconnecting passage130, and optionally into at least one of the passages 116, 118, to theshape of at least the interconnecting passage 130.

The distal end portion 104 of the device 100 is expanded, for exampleupon inflation of a balloon or by self-expansion, so as to increase thediameter of the distal end portion 104 and anchor the distal end portion104 against the inner wall of the vein 118. The catheter may be adaptedto expand the intermediate portion 106 of the device 100, for example byinflation of a balloon, so that the interconnecting passage 130 can bewidened or dilated to obtain blood flow (e.g., sufficient blood flow)from the artery 116 to the vein 118. The proximal end portion 102 of thedevice 100 is expanded, for example upon inflation of a balloon or byself-expansion, so as to increase the diameter of the proximal endportion 102 and anchor the proximal end portion 102 against the innerwall of the artery 116.

After the end portions 102, 104 of the device 100 are expanded, forexample due to self-expansion and/or balloon expansion, and with orwithout improving expansion after deployment, the catheter and theguidewire are withdrawn from the patient's body. In this way, the device100 is anchored or fixed in position within the vein 118, the artery116, and the interconnecting passage 130 as shown in FIG. 9. Inembodiments in which the device 100 comprises a stent-graft, the graft,which can form a fluid-tight passage between the artery 116 and the vein118, can inhibit or prevent blood from flowing antegrade in the vein 118because such passageway is blocked, which can be in addition to orinstead of a blocking agent in the vein 118.

The catheter may be adapted to selectively expand the proximal endportion 102, the distal end portion 104, and/or the intermediate portion106 of the device 100 individually or in combination, for example by theprovision of two or more separately inflatable balloons or balloonportions, a single balloon configured to expand all of the portions ofthe device 100 simultaneously, or a single balloon configured to expandone or more selected portions of the device 100. For example, the endportions 102, 104 may be self-expanding, and the intermediate portion106 may be expanded by a balloon to dilate the passage 130. In someembodiments including balloon expansion, all or selected parts of thedevice 100 may be expanded, for example, simultaneously by a balloonacross the entire length of the device 100 or by a plurality of balloonslongitudinally spaced to selectively inflate selected parts of thedevice 100, and/or sequentially by a balloon or plurality of balloons.In some embodiments including at least partial self-expansion, all orselected parts of the device 100 may be expanded, for example, byproximal retraction of a sheath over or around the device 100, which canlead to deployment of the device 100 from distal to proximal as thesheath is proximally retracted. Deployment of the device 100 proximal todistal and deployment of the device 100 intermediate first then the endsare also possible. In some embodiments, for example embodiments in whichthe device 100 is at least partially conical or tapered, a conical ortapered balloon may be used to at least partially expand the device 100.In certain such embodiments, a portion of the balloon proximate to thevein 118 may have a larger diameter than a portion of the balloonproximate to the artery 116, for example such that the device 100 canadapt to changing vein diameters due to any increase in pressure orblood flow in the vein 118.

Other steps may be included in the procedure. For example, before thedevice 100 is deployed, a balloon catheter may be guided to theinterconnecting passage 130 and positioned so that an inflatable balloonportion of the catheter lies in the interconnecting passage 130. Uponinflation of the balloon, the balloon pushes against the walls of theinterconnecting passage 130 to widen or dilate the interconnectingpassage 130 to ease subsequent insertion of the device 100.

FIG. 10 illustrates another device 134 for providing fluid flow throughat least one passage. The device 134 includes a mesh 136 and a polymertube 108. The mesh 136 is shown as being on the outside of the polymertube 108, but as described herein could also or alternatively be on aninside of the polymer tube and/or within the polymer tube 108. Asdescribed with respect to the device 100, the device 134 includes aproximal end portion 102, a distal end portion 104, and an intermediateportion 106. In the embodiment illustrated in FIG. 10, the mesh 136extends along the entire length of the device 134, including along theintermediate portion 106.

In some embodiments, the spacing of filaments or struts of the mesh 136varies along the length of the device 134. For example, winding densityof a woven or layered filamentary mesh may be varied and/or a windowsize pattern of a cut mesh may be varied.

In some embodiments, the spacing may be relatively small in the proximalend portion 102 and the distal end portions 104, and the spacing may berelatively large in the intermediate portion 106. In other words, thedensity or window size of the mesh 136 may be relatively low in theintermediate portion 106, and the density or window size of the mesh 136may be relatively high in the end portions 102, 104. In certain suchembodiments, the intermediate portion 106 may be flexible in comparisonto the end portions 102, 104. The relatively rigid end portions 102, 104may engage and anchor in passages. Although the mesh 136 in theintermediate portion 106 may be subject to stress such as cyclic stress,in use, the relatively high flexibility of the intermediate portion 106due to the low density or window size allows the impact of the stress tobe low because the intermediate portion 106 can flex in response to thestress. The risk of fatigue failure of the device 134, and particularlythe filaments or struts 138 of the mesh 136, may therefore be reduced incomparison to a device having uniform flexibility along its entirelength.

In some embodiments, the spacing may be relatively large in the proximalend portion 102 and the distal end portions 104, and the spacing may berelatively small in the intermediate portion 106. In other words, thedensity of the mesh 136 may be relatively high (or the window size ofthe mesh 136 may be relatively low) in the intermediate portion 106, andthe density of the mesh 136 may be relatively low (or the window size ofthe mesh 136 may be relatively high) in the end portions 102, 104. Incertain such embodiments, the intermediate portion 106 may have radialstrength sufficient to inhibit or prevent collapse of the passage 130,yet still, flexible enough to flex in response to stress such as cyclicstress. The end portions 102, 104 may engage and anchor in passages.

FIG. 11 illustrates another device or implant or prosthetic 140 forproviding fluid flow through at least one passage. As described withrespect to the device 100, the device 140 includes a proximal endportion 102, a distal end portion 104, and an intermediate portion 106.The device 140 includes a polymer tube 108 and a support structureincluding a first mesh 142 and a second mesh 144. The first mesh 142extends from the proximal end portion 102 toward (e.g., into) theintermediate portion 106 and optionally into the distal end portion 104.The second mesh 144 extends from the distal end portion 104 toward(e.g., into) the intermediate portion 106 and optionally into theproximal end portion 102. The meshes 142, 144 thereby overlap each otherat least in the intermediate portion 106. Both meshes 142, 144 may be onthe outside of the tube 108, on the inside of the tube 108, or embeddedwithin the tube 108, or one mesh may be on the outside of the tube 108,on the inside of the tube 108, or embedded within the tube 108 while theother mesh is differently on the outside of the tube 108, on the insideof the tube 108, or embedded within the tube 108 (e.g., one mesh insidethe tube 108 and one mesh outside the tube 108). The meshes 142, 144 maybe formed, for example, by winding wire in a lattice configurationaround or inside the polymer tube 108, by placing a cut tube around orinside the polymer tube 108, by being embedded in the polymer tube 108,combinations thereof, and the like.

In some embodiments, the density of the meshes 142, 144 is relativelyhigh (or the window size of the meshes 142, 144 is relatively low) intheir respective end portions 102, 104 and decreases in density (orincreases in window size) towards the intermediate portion 106. Thetotal winding density (e.g., the winding density of both meshes 142,144, taken together) may be lower in the intermediate portion 106 thanin the end portions 102, 104, or the total window size (e.g., the windowsize of both meshes 142, 144, taken together) may be higher in theintermediate portion 106 than in the end portions 102, 104. In certainsuch embodiments, the intermediate portion 106 is relatively flexible incomparison to the end portions 102, 104. In some embodiments, the meshes142, 144 do not extend into the intermediate portion, and absence of amesh could cause the intermediate portion 106 to be relatively flexiblein comparison to the end portions 102, 104. In some embodiments, aswindow size increases (e.g., longitudinally along a tapered portion ofthe device 140), the density decreases, the mesh coverage decreases,and/or the porosity increases because the width of the struts and/orfilaments remains substantially constant or constant or does notincrease in the same proportion as the window size, which could providea change in flexibility along a longitudinal length.

The first and second meshes 142, 144 may include different materials,which can allow optimization of the properties of each of the respectivedistal and proximal end portions 102, 104 of the device 140 for aparticular application of the device 140. For example, the second mesh144 at the distal end portion 104 of the device 140 may include arelatively flexible metallic alloy for ease of insertion through aninterconnecting passage between two blood vessels, while the first mesh142 at the proximal end portion 102 of the device 140 may include arelatively inelastic metallic alloy to provide a high degree ofresilience at the proximal end portion 104 to anchor the device 140firmly in position. The first and second meshes 142, 144 could includethe same material composition (e.g., both including nitinol) butdifferent wire diameters (gauge) or strut thicknesses.

FIG. 12 illustrates another device or implant or prosthetic 150 forproviding fluid flow through at least one passage. The device 150includes a support structure (e.g., stent) 152 and a graft 154. Asdescribed with respect to the device 100, the device 150 includes aproximal end portion 102, a distal end portion 104, and an intermediateportion 106. The proximal end portion 102 includes a cylindrical orsubstantially cylindrical portion and the distal end portion 104includes a cylindrical or substantially cylindrical portion. Thediameter of the proximal end portion 102 is smaller than the diameter ofthe distal end portion 104. In some embodiments, the diameter of theproximal end portion 102 is larger than the diameter of the distal endportion 104. The intermediate portion 106 has a tapered or frustoconicalshape between the proximal end portion 102 and the distal end portion104. The stent 152 may include filaments (e.g., woven, layered), a cuttube or sheet, and/or combinations thereof.

Parameters of the stent 152 may be uniform or substantially uniformacross a portion and/or across multiple portions, or may vary within aportion and/or across multiple portions. For example, the stent 152 atthe proximal end portion 102 may include a cut tube or sheet, the stent152 at the distal end portion 102 may include a cut tube or sheet, andthe stent 152 at the intermediate portion 106 may include filaments(e.g., woven or layered). Certain such embodiments may provide goodanchoring by the proximal end portion 102 and the distal end portion 104and good flexibility (e.g., adaptability to third passage sizes anddynamic stresses) of the intermediate portion 106.

The stent 152 may include different materials in different portions. Forexample, the stent 152 at the proximal end portion 102 may includechromium cobalt and/or tantalum, the stent 152 at the distal end portion104 may include nitinol, and the stent 152 at the intermediate portion106 may include nitinol. Certain such embodiments may provide goodanchoring and/or wall apposition by the device 150 in each deploymentareas (e.g., the proximal end portion 102 engaging sidewalls of anartery, the distal end portion 104 engaging sidewalls of a vein, and theintermediate portion 106 engaging sidewalls of the passage between theartery and the vein). In some embodiments in which the distal endportion 104 is self-expanding, the distal end portion 104 can adapt dueto changing vessel diameter (e.g., if vein diameter increases due to anincrease in pressure or blood flow), for example by furtherself-expanding.

Combinations of support structure materials and types are also possible.For example, the stent 152 at the proximal portion may include a cuttube or sheet including chromium cobalt and/or tantalum, the stent 152at the distal end portion 104 may include a cut tube or sheet includingnitinol, and the stent 152 at the intermediate portion 106 may includefilaments including nitinol.

In embodiments in which the stent 152 includes at least one portionincluding a cut tube or sheet, the cut pattern may be the same. Forexample, the cut pattern may be the same in the proximal end portion 102and the distal end portion 104, but proportional to the change indiameter. In some embodiments, the window size or strut density isuniform or substantially uniform within a portion 102, 104, 106, withintwo or more of the portions 102, 104, 106, and/or from one end of thestent 152 to the other end of the stent 152. In embodiments in which thestent 152 includes at least one portion including filaments, the windingmay be the same. For example, the winding may be the same in theproximal end portion 102 and the distal end portion 104, but changed dueto the change in diameter. In some embodiments, the winding density orporosity is uniform or substantially uniform within a portion 102, 104,106, within two or more of the portions 102, 104, 106, and/or from oneend of the stent 152 to the other end of the stent 152. In embodimentsin which the stent 152 includes at least one portion including a cuttube or sheet and at least one portion including filaments, the cutpattern and winding may be configured to result in a uniform orsubstantially uniform density. Non-uniformity is also possible, forexample as described herein.

The graft 154 may include materials and attachment to the stent 152 asdescribed with respect to the tube 108. The graft 154 generally forms afluid-tight passage for at least a portion of the device 150. Althoughillustrated as only being around the intermediate portion 106, the graft154 may extend the entire length of the device 150, or may partiallyoverlap into at least one of the cylindrical end portions 102, 104.

FIG. 13 illustrates another device 160 for providing fluid flow throughat least one passage. The device 160 includes a support structure (e.g.,stent) and a graft 164. As described with respect to the device 100, thedevice 160 includes a proximal end portion 102, a distal end portion104, and an intermediate portion 106. The proximal end portion 102includes a tapered or frustoconical portion and the distal end portion104 includes a tapered or frustoconical portion. The diameter of theproximal end of the proximal end portion 102 is smaller than thediameter of the distal end of the distal end portion 104. In someembodiments, the diameter of the proximal end of the proximal endportion 102 is larger than the diameter of the distal end of the distalend portion 104. The intermediate portion 106 has a tapered orfrustoconical shape between the proximal end portion 102 and the distalend portion 104. In some embodiments, the angle of inclination of theportions 102, 104, 106 is the same or substantially the same (e.g., asillustrated in FIG. 13). In some embodiments, the angle of inclinationof at least one portion is sharper or narrower than at least one otherportion. The frustoconical proximal end portion 102 and distal endportion 104 may allow better anchoring in a body passage, for examplebecause arteries tend to taper with distance from the heart and veinstend to taper with distance towards the heart, and the end portions 102,104 can be configured to at least partially correspond to suchanatomical taper.

FIG. 12 illustrates a device 150 comprising a first cylindrical orstraight portion, a conical or tapered portion, and second cylindricalor straight portion. FIG. 13 illustrates a device 160 comprising one ormore conical or tapered sections (e.g., the entire device 160 beingconical or tapered or comprising a plurality of conical or taperedsections). In some embodiments, combinations of the devices 150, 160 arepossible. For example, a device may comprise a cylindrical or straightportion and a conical or tapered portion for the remainder of thedevice. In certain such embodiments, the device may have a lengthbetween about 1 cm and about 10 cm (e.g., about 5 cm), which includes acylindrical or straight portion having a diameter between about 1 mm andabout 5 mm (e.g., about 3 mm) and a length between about 0.5 cm andabout 4 cm (e.g., about 2 cm) and a conical or tapered portion having adiameter that increases from the diameter of the cylindrical or straightportion to a diameter between about 3 mm and about 10 mm (e.g., about 5mm) and a length between about 1 cm and about 6 cm (e.g., about 3 cm).Such a device may be devoid of another cylindrical or conical portionthereafter.

As described above with respect to the support structure 152, thesupport structure 162 may include filaments (e.g., woven, layered), acut tube or sheet, the same materials, different materials, andcombinations thereof.

The graft 164 may include materials and attachment to the stent 162 asdescribed with respect to the tube 108. The graft 164 generally forms afluid-tight passage for at least a portion of the device 160. Althoughillustrated as only being around the intermediate portion 106, the graft164 may extend the entire length of the device 160, or may partiallyoverlap into at least one of the frustoconical end portions 102, 104.

In some embodiments, a combination of the device 150 and the device 160are possible. For example, the proximal end portion 102 can becylindrical or substantially cylindrical (e.g., as in the device 150),the distal end portion 104 can be tapered or frustoconical (e.g., as inthe device 160), with the proximal end portion 102 having a largerdiameter than the distal end of the distal end portion 104. For anotherexample, the proximal end portion 102 can be tapered or frustoconical(e.g., as in the device 160), the distal end portion 104 can becylindrical or substantially cylindrical (e.g., as in the device 150),with the proximal end of the proximal end portion 102 having a largerdiameter than the distal end portion 104. In each example, theintermediate portion 106 can have a tapered or frustoconical shapebetween the proximal end portion 102 and the distal end portion 104.

An example deployment device for the implantable devices describedherein is described in U.S. patent application Ser. No. 12/545,982,filed Aug. 24, 2009, and U.S. patent application Ser. No. 13/486,249,filed Jun. 1, 2012, the entire contents of each of which is herebyincorporated by reference. The device generally includes a handle at theproximal end with a trigger actuatable by a user and a combination oftubular member at the distal end configured to be pushed and/or pulledupon actuation of the trigger to release the device. Other deliverydevices are also possible. The delivery device may include a portionslidable over a guidewire (e.g., a guidewire that has been navigatedbetween the artery and the vein via a tissue traversing needle) and/ormay be trackable through a lumen of a catheter.

Although certain embodiments and examples are shown or described hereinin detail, various combinations, sub-combinations, modifications,variations, substitutions, and omissions of the specific features andaspects of those embodiments are possible, some of which will now bedescribed by way of example only.

The device, for example a stent of the device, a mesh of the device, asupport structure of the device, etc., may be self-expanding. Forexample, a mesh may include a shape-memory material, such as nitinol,which is capable of returning or configured to return to a pre-set shapeafter undergoing deformation. In some embodiments, the stent may bemanufactured to a shape that is desired in the expanded configuration,and is compressible to fit inside a sleeve for transport on a catheterto a vascular site. To deploy and expand the stent, the sleeve is drawnback from the stent to allow the shape memory material to return to thepre-set shape, which can anchor the stent in the passages, and which maydilate the passages if the stent has sufficient radial strength. The useof a balloon catheter is not required to expand a fully self-expandingstent, but may be used, for example, to improve or optimize thedeployment.

A device may include one or more self-expanding portions, and one ormore portions which are expandable by deformation, for example using aballoon catheter. For example, in the embodiment shown in FIG. 11, thefirst mesh 142 may include stainless steel expandable by a ballooncatheter, and the second mesh 144 may include nitinol for self-expansionupon deployment.

With respect to any of the embodiments described herein, the polymertube 108, including the grafts 154, 164, may include any suitablecompliant or flexible polymer, such as PTFE, silicone, polyethyleneterephthalate (PET), polyurethane such as polycarbonate aromaticbiodurable thermoplastic polyurethane elastomer (e.g., ChronoFlex C® 80Aand 55D medical grade, available from AdvanSource Biomaterials ofWilmington, Mass.), combinations thereof, and the like. The polymer tube108 may include biodegradable, bioabsorbable, or biocompatible polymer(e.g., polylactic acid (PLA), polyglycolic acid (PGA),polyglycolic-lactic acid (PLGA), polycaprolactone (PCL),polyorthoesters, polyanhydrides, combinations thereof, etc.). Thepolymer may be in tube form before interaction with a support structure(e.g., stent), or may be formed on, in, and/or around a supportstructure (e.g., stent). For example, the polymer may include spunfibers, a dip-coating, combinations thereof, and the like. In someembodiments, for example when the device is to be deployed within asingle blood vessel, the device may omit the tube. In certain suchembodiments, the intermediate portion of the stent may include a meshwith a low winding density or high window size, while the end portionsof the stent include a mesh with a higher winding density or lowerwindow size, the mesh being generally tubular to define a pathway forfluid flow through the center of the mesh. In some embodiments, thepolymer tube 108 includes a lip (e.g., comprising the same or differentmaterial), which can help form a fluid-tight seal between the polymertube 108 and the body passages. The seal may be angled, for example toaccount for angled positioning of the polymer tube 108 between bodypassages. In some embodiments, the polymer tube 108 may extendlongitudinally beyond the support structure in at least one direction,and the part extending beyond is not supported by the support structure.

The mesh may include any suitable material, such as nickel, titanium,chromium, cobalt, tantalum, platinum, tungsten, iron, manganese,molybdenum, combinations thereof (e.g., nitinol, chromium cobalt,stainless steel), and the like. The mesh may include biodegradable,bioabsorbable, or biocompatible polymer (e.g., polylactic acid (PLA),polyglycolic acid (PGA), polyglycolic-lactic acid (PLGA),polycaprolactone (PCL), polyorthoesters, polyanhydrides, combinationsthereof, etc.) and/or glass, and may lack metal. Different materials maybe used for portions of the mesh or within the same mesh, for example aspreviously described with reference to FIG. 11. For example, the mesh114 at the distal end portion 104 and the mesh 112 at the proximal endportion 102 of the device 100 may include different materials. Foranother example, the mesh 112, and/or the mesh 114, may include ametallic alloy (e.g., comprising cobalt, chromium, nickel, titanium,combinations thereof, and the like) in combination with a different typeof metallic alloy (e.g., a shape memory alloy in combination with anon-shape memory alloy, a first shape memory alloy in combination with asecond shape memory alloy different than the first shape memory alloy, aclad material (e.g., comprising a core including a radiopaque materialsuch as titanium, tantalum, rhenium, bismuth, silver, gold, platinum,iridium, tungsten, etc.)) and/or a non-metallic material such as apolymer (e.g., polyester fiber), carbon, and/or bioabsorbable glassfiber. In some embodiments, at least one mesh 112, 114 comprises nitinoland stainless steel. The nitinol may allow some self-expansion (e.g.,partial and/or full self-expansion), and the mesh could then be furtherexpanded, for example using a balloon.

Although generally illustrated in FIGS. 8, 10, and 11 as a wovenfilament mesh, any other structure that can provide the desired degreeof resilience may be used. For example, layers of filaments wound inopposite directions may be fused at the filament ends to provide anexpandable structure. For another example, a metal sheet may be cut(e.g., laser cut, chemically etched, plasma cut, etc.) to formperforations and then heat set in a tubular formation or a metal tube(e.g., hypotube) may be cut (e.g., laser cut, chemically etched, plasmacut, etc.) to form perforations. A cut tube (including a cut sheetrolled into a tube) may be heat set to impart an expanded configuration.

Filaments or wires or ribbons that may be woven or braided, or layeredor otherwise arranged, are generally elongate and have a circular, oval,square, rectangular, etc. transverse cross-section. Example non-wovenfilaments can include a first layer of filaments wound in a firstdirection and a second layer of filaments wound in a second direction,at least some of the filament ends being coupled together (e.g., bybeing coupled to an expandable ring). Example braid patterns includeone-over-one-under-one, a one-over-two-under-two, atwo-over-two-under-two, and/or combinations thereof, although otherbraid patterns are also possible. At filament crossings, filaments maybe helically wrapped, cross in sliding relation, and/or combinationsthereof. Filaments may be loose (e.g., held together by the weave)and/or include welds, coupling elements such as sleeves, and/orcombinations thereof. Ends of filaments can be bent back, crimped (e.g.,end crimp with a radiopaque material such as titanium, tantalum,rhenium, bismuth, silver, gold, platinum, iridium, tungsten, etc. thatcan also act as a radiopaque marker), twisted, ball welded, coupled to aring, combinations thereof, and the like. Weave ends may includefilament ends and/or bent-back filaments, and may include open cells,fixed or unfixed filaments, welds, adhesives, or other means of fusion,radiopaque markers, combinations thereof, and the like. Parameters ofthe filaments may be uniform or substantially uniform across a portionand/or across multiple portions, or may vary within a portion and/oracross multiple portions. For example, the proximal end portion 102 mayinclude a first parameter and the distal end portion 104 may include asecond parameter different than the first braid pattern. For anotherexample, the proximal end portion 102 and the distal end portion 104 mayeach include a first parameter and the intermediate portion 106 mayinclude a second parameter different than the parameter. For yet anotherexample, at least one of the proximal end portion 102, the distal endportion 104, and the intermediate portion 106 may include both a firstparameter and a second parameter different than the first parameter.Filament parameters may include, for example, filament type, filamentthickness, filament material, quantity of filaments, weave pattern,layering, wind direction, pitch, angle, crossing type, filament couplingor lack thereof, filament end treatment, weave end treatment, layeringend treatment, quantity of layers, presence or absence of welds,radiopacity, braid pattern, density, porosity, filament angle, braiddiameter, winding diameter, and shape setting.

Tubes or sheets may be cut to form strut or cell patterns, struts beingthe parts of the tube or sheet left after cutting and cells orperforations or windows being the parts cut away. A tube (e.g.,hypotube) may be cut directly, or a sheet may be cut and then rolledinto a tube. The tube or sheet may be shape set before or after cutting.The tube or sheet may be welded or otherwise coupled to itself, toanother tube or sheet, to filaments, to a graft material, etc. Cuttingmay be by laser, chemical etchant, plasma, combinations thereof, and thelike. Example cut patterns include helical spiral, weave-like, coil,individual rings, sequential rings, open cell, closed cell, combinationsthereof, and the like. In embodiments including sequential rings, therings may be coupled using flex connectors, non-flex connectors, and/orcombinations thereof. In embodiments including sequential rings, therings connectors (e.g., flex, non-flex, and/or combinations thereof) mayintersect ring peaks, ring valleys, intermediate portions of struts,and/or combinations thereof (e.g., peak-peak, valley-valley, mid-mid,peak-valley, peak-mid, valley-mid, valley-peak, mid-peak, mid-valley).The tube or sheet or sections thereof may be ground and/or polishedbefore or after cutting. Interior ridges may be formed, for example toassist with fluid flow. Parameters of the cut tube or sheet may beuniform or substantially uniform across a portion and/or across multipleportions, or may vary within a portion and/or across multiple portions.For example, the proximal end portion 102 may include a first parameterand the distal end portion 104 may include a second parameter differentthan the first parameter. For another example, the proximal end portion102 and the distal end portion 104 may each include a first parameterand the intermediate portion 106 may include a second parameterdifferent than the parameter. For yet another example, at least one ofthe proximal end portion 102, the distal end portion 104, and theintermediate portion 106 may include both a first parameter and a secondparameter different than the first parameter. Cut tube or sheetparameters may include, for example, radial strut thickness,circumferential strut width, strut shape, cell shape, cut pattern, cuttype, material, density, porosity, tube diameter, and shape setting.

In some embodiments, the perforations may provide the mesh with arelatively flexible intermediate portion and relatively stiff endportions. The supporting structure may instead be an open-cell foamdisposed within the tube.

Filaments of a stent, stent-graft, or a portion thereof, and/or strutsof a cut stent, stent-graft, or a portion thereof, may be surfacemodified, for example to carry medications such as thrombosis modifiers,fluid flow modifiers, antibiotics, etc. Filaments of a stent,stent-graft, or a portion thereof, and/or struts of a cut stent,stent-graft, or a portion thereof, may be at least partially coveredwith a coating including medications such as thrombosis modifiers, fluidflow modifiers, antibiotics, etc., for example embedded within a polymerlayer or a series of polymer layers, which may be the same as ordifferent than the polymer tube 108.

Thickness (e.g., diameter) of filaments of a stent, stent-graft, or aportion thereof, and/or struts of a cut stent, stent-graft, or a portionthereof, may be between about 0.0005 inches and about 0.02 inches,between about 0.0005 inches and about 0.015 inches, between about 0.0005inches and about 0.01 inches, between about 0.0005 inches and about0.008 inches, between about 0.0005 inches and about 0.007 inches,between about 0.0005 inches and about 0.006 inches, between about 0.0005inches and about 0.005 inches, between about 0.0005 inches and about0.004 inches, between about 0.0005 inches and about 0.003 inches,between about 0.0005 inches and about 0.002 inches, between about 0.0005inches and about 0.001 inches, between about 0.001 inches and about 0.02inches, between about 0.001 inches and about 0.015 inches, between about0.001 inches and about 0.01 inches, between about 0.001 inches and about0.008 inches, between about 0.001 inches and about 0.007 inches, betweenabout 0.001 inches and about 0.006 inches, between about 0.001 inchesand about 0.005 inches, between about 0.001 inches and about 0.004inches, between about 0.001 inches and about 0.003 inches, between about0.001 inches and about 0.002 inches, between about 0.002 inches andabout 0.02 inches, between about 0.002 inches and about 0.015 inches,between about 0.002 inches and about 0.01 inches, between about 0.002inches and about 0.008 inches, between about 0.002 inches and about0.007 inches, between about 0.002 inches and about 0.006 inches, betweenabout 0.002 inches and about 0.005 inches, between about 0.002 inchesand about 0.004 inches, between about 0.002 inches and about 0.003inches, between about 0.003 inches and about 0.02 inches, between about0.003 inches and about 0.015 inches, between about 0.003 inches andabout 0.01 inches, between about 0.003 inches and about 0.008 inches,between about 0.003 inches and about 0.007 inches, between about 0.003inches and about 0.006 inches, between about 0.003 inches and about0.005 inches, between about 0.003 inches and about 0.004 inches, betweenabout 0.004 inches and about 0.02 inches, between about 0.004 inches andabout 0.015 inches, between about 0.004 inches and about 0.01 inches,between about 0.004 inches and about 0.008 inches, between about 0.004inches and about 0.007 inches, between about 0.004 inches and about0.006 inches, between about 0.004 inches and about 0.005 inches, betweenabout 0.005 inches and about 0.02 inches, between about 0.005 inches andabout 0.015 inches, between about 0.005 inches and about 0.01 inches,between about 0.005 inches and about 0.008 inches, between about 0.005inches and about 0.007 inches, between about 0.005 inches and about0.006 inches, between about 0.006 inches and about 0.02 inches, betweenabout 0.006 inches and about 0.015 inches, between about 0.006 inchesand about 0.01 inches, between about 0.006 inches and about 0.008inches, between about 0.006 inches and about 0.007 inches, between about0.007 inches and about 0.02 inches, between about 0.007 inches and about0.015 inches, between about 0.007 inches and about 0.01 inches, betweenabout 0.007 inches and about 0.008 inches, between about 0.008 inchesand about 0.02 inches, between about 0.008 inches and about 0.015inches, between about 0.008 inches and about 0.01 inches, between about0.01 inches and about 0.02 inches, between about 0.01 inches and about0.015 inches, or between about 0.015 inches and about 0.02 inches. Otherthicknesses are also possible, including thicknesses greater than orless than the identified thicknesses. Filaments and/or struts comprisingcertain materials (e.g., biodegradable material, materials with lessrestoring force, etc.) may be thicker than the identified thicknesses.

Thicknesses of filaments and/or struts may be based, for example, on atleast one of device or device portion size (e.g., diameter and/orlength), porosity, radial strength, material, quantity of filamentsand/or struts, cut pattern, weave pattern, layering pattern, and thelike. For example, larger filament and/or strut thicknesses (e.g.,greater than about 0.006 inches) may be useful for large devices ordevice portions used to treat large vessels such as coronary vessels,mid-sized filament and/or strut thicknesses (e.g., between about 0.003inches and about 0.006 inches) may be useful for mid-sized used to treatmid-sized vessels such as peripheral vessels, and small filament and/orstrut thicknesses (e.g., less than about 0.003 inches) may be useful forsmall devices or device portions used to treat small vessels such asveins and neurological vessels.

The internal or external diameter of a stent, a stent-graft, or a firstend portion, second end portion, intermediate portion, or subportionthereof, for example taking into account filament or strut thickness,may be between about 1 mm and about 12 mm, between about 1 mm and about10 mm, between about 1 mm and about 8 mm, between about 1 mm and about 6mm, between about 1 mm and about 4 mm, between about 1 mm and about 2mm, between about 2 mm and about 12 mm, between about 2 mm and about 10mm, between about 2 mm and about 8 mm, between about 2 mm and about 6mm, between about 2 mm and about 4 mm, between about 4 mm and about 12mm, between about 4 mm and about 10 mm, between about 4 mm and about 8mm, between about 4 mm and about 6 mm, between about 6 mm and about 12mm, between about 6 mm and about 10 mm, between about 6 mm and about 8mm, between about 8 mm and about 12 mm, between about 8 mm and about 10mm, or between about 10 mm and about 12 mm. Certain such diameters maybe suitable for treating, for example, coronary vessels. The internal orexternal diameter of a stent, a stent-graft, or a portion thereof, forexample taking into account filament or strut thickness, may be betweenabout 1 mm and about 10 mm, between about 1 mm and about 8 mm, betweenabout 1 mm and about 6 mm, between about 1 mm and about 4 mm, betweenabout 1 mm and about 2 mm, between about 2 mm and about 10 mm, betweenabout 2 mm and about 8 mm, between about 2 mm and about 6 mm, betweenabout 2 mm and about 4 mm, between about 4 mm and about 10 mm, betweenabout 4 mm and about 8 mm, between about 4 mm and about 6 mm, betweenabout 6 mm and about 10 mm, between about 6 mm and about 8 mm, orbetween about 8 mm and about 10 mm. Certain such diameters may besuitable for treating, for example, veins. The internal or externaldiameter of a stent, a stent-graft, or a portion thereof, for exampletaking into account filament or strut thickness, may be between about 6mm and about 25 mm, between about 6 mm and about 20 mm, between about 6mm and about 15 mm, between about 6 mm and about 12 mm, between about 6mm and about 9 mm, between about 9 mm and about 25 mm, between about 9mm and about 20 mm, between about 9 mm and about 15 mm, between about 9mm and about 12 mm, between about 12 mm and about 25 mm, between about12 mm and about 20 mm, between about 12 mm and about 15 mm, betweenabout 15 mm and about 25 mm, between about 15 mm and about 20 mm, orbetween about 20 mm and about 25 mm. Certain such diameters may besuitable for treating, for example, peripheral vessels. The internal orexternal diameter of a stent, a stent-graft, or a portion thereof, forexample taking into account filament or strut thickness, may be betweenabout 20 mm and about 50 mm, between about 20 mm and about 40 mm,between about 20 mm and about 35 mm, between about 20 mm and about 30mm, between about 30 mm and about 50 mm, between about 30 mm and about40 mm, between about 30 mm and about 35 mm, between about 35 mm andabout 50 mm, between about 35 mm and about 40 mm, or between about 40 mmand about 50 mm. Certain such diameters may be suitable for treating,for example, aortic vessels. Other diameters are also possible,including diameters greater than or less than the identified diameters.The diameter of the device may refer to the diameter of the first endportion, the second end portion, or the intermediate portion, each ofwhich may be in expanded or unexpanded form. The diameter of the devicemay refer to the average diameter of the device when all of the portionsof the device are in either expanded or unexpanded form.

The length of a stent, a stent-graft, or a first end portion, second endportion, intermediate portion, or subportion thereof may be betweenabout 5 mm and about 150 mm, between about 5 mm and about 110 mm,between about 5 mm and about 70 mm, between about 5 mm and about 50 mm,between about 5 mm and about 25 mm, between about 5 mm and about 20 mm,between about 5 mm and about 10 mm, between about 10 mm and about 150mm, between about 10 mm and about 110 mm, between about 10 mm and about70 mm, between about 10 mm and about 50 mm, between about 10 mm andabout 25 mm, between about 10 mm and about 20 mm, between about 20 mmand about 150 mm, between about 20 mm and about 110 mm, between about 20mm and about 70 mm, between about 20 mm and about 50 mm, between about20 mm and about 25 mm, between about 25 mm and about 150 mm, betweenabout 25 mm and about 110 mm, between about 25 mm and about 70 mm,between about 25 mm and about 50 mm, between about 50 mm and about 150mm, between about 50 mm and about 110 mm, between about 50 mm and about70 mm, between about 70 mm and about 150 mm, between about 70 mm andabout 110 mm, or between about 110 mm and about 150 mm. Other lengthsare also possible, including lengths greater than or less than theidentified lengths.

The porosity of a stent, a stent-graft, or a first end portion, secondend portion, intermediate portion, or subportion thereof may be betweenabout 5% and about 95%, between about 5% and about 50%, between about 5%and about 25%, between about 5% and about 10%, between about 10% andabout 50%, between about 10% and about 25%, between about 25% and about50%, between about 50% and about 95%, between about 50% and about 75%,between about 50% and about 60%, between about 60% and about 95%,between about 75% and about 90%, between about 60% and about 75%, andcombinations thereof. The density of a stent may be inverse to theporosity of that stent. The porosity of a portion of a stent covered bya graft may be about 0%. The porosity may vary by objectives for certainportions of the stent. For example, the intermediate portion may have alow porosity to increase fluid flow through the device, while endportions may have lower porosity to increase flexibility and wallapposition.

The radial strength or compression resistance of a stent, a stent-graft,or a first end portion, second end portion, intermediate portion, orsubportion thereof may be between about 0.1 N/mm and about 0.5 N/mm,between about 0.2 N/mm and about 0.5 N/mm, between about 0.3 N/mm andabout 0.5 N/mm, between about 0.1 N/mm and about 0.3 N/mm, between about0.1 N/mm and about 0.2 N/mm, between about 0.2 N/mm and about 0.5 N/mm,between about 0.2 N/mm and about 0.3 N/mm, or between about 0.3 N/mm andabout 0.5 N/mm.

The values of certain parameters of a stent, a stent-graft, or a firstend portion, second end portion, intermediate portion, or subportionthereof may be linked (e.g., proportional). For example, a ratio of athickness of a strut or filament to a diameter of a device portioncomprising that strut or filament may be between about 1:10 and about1:250, between about 1:25 and about 1:175, or between about 1:50 andabout 1:100. For another example, a ratio of a length of a device orportion thereof to a diameter of a device or a portion thereof may bebetween about 1:1 and about 50:1, between about 5:1 and about 25:1, orbetween about 10:1 and about 20:1.

Portions of the device may include radiopaque material. For example,filaments and/or struts a stent, a stent-graft, or a first end portion,second end portion, intermediate portion, or subportion thereof maycomprise (e.g., be at least partially made from) titanium, tantalum,rhenium, bismuth, silver, gold, platinum, iridium, tungsten,combinations thereof, and the like. For another example, filamentsand/or struts of a stent, stent-graft, or a portion thereof may comprise(e.g., be at least partially made from) a material having a densitygreater than about 9 grams per cubic centimeter. Separate radiopaquemarkers may be attached to certain parts of the device. For example,radiopaque markers can be added to the proximal end of the device orparts thereof (e.g., a proximal part of the intermediate portion, aproximal part of the distal portion), the distal end of the device orparts thereof (e.g., a distal part of the intermediate portion, a distalpart of the proximal portion), and/or other parts. A radiopaque markerbetween ends of a device may be useful, for example, to demarcatetransitions between materials, portions, etc. Radiopacity may varyacross the length of the device. For example, the proximal portion couldhave a first radiopacity (e.g., due to distal portion material and/orseparate markers) and the distal portion could have a second radiopacity(e.g., due to distal portion material and/or separate markers) differentthan the first radiopacity.

In some embodiments, the device includes a polymer tube, and nosupporting structure is provided. The intermediate portion of such adevice may be relatively more flexible than the end portions by, forexample, decreasing the wall thickness of the polymer tube within theintermediate portion.

When a mesh or other supporting structure is provided in combinationwith a polymer tube, the supporting structure may be located around theoutside of the tube, in the inner bore of the tube, or embedded within awall of the tube. More than one supporting structure may be provided, inwhich case each supporting structure may have a different location withrespect to the tube.

One or both of the end portions of the device may include anchoringelements such as hooks, protuberances, or barbs configured to grasp orgrip inner sidewalls of a blood vessel. The radial force of the endportions after expansion may be sufficient to grasp or grip innersidewalls of a blood vessel without anchoring elements.

There need not be a well-defined transition between the intermediate andend portions. For example, mesh type, material, wall thickness,flexibility, etc. may gradually change from an end portion toward anintermediate portion or from an intermediate portion toward an endportion.

The flexibility of the device may increase gradually when moving from anend portion towards the intermediate portion, for example as describedwith respect to the devices 134, 140. The change in flexibility may bedue to change in mesh density (e.g., winding density, window size), tubethickness, or other factors. The flexibility of the device may beuniform or substantially uniform along the entire length of the supportstructure (e.g., stent), or along certain portions of the supportstructure (e.g., along an entire end portion, along the entireintermediate portion, along one end portion and the intermediate portionbut not the other end portion, etc.).

While the devices described herein may be particularly suitable for useas a transvascular shunt in percutaneous surgery, the devices could beused in many other medical applications. For example, the devices couldbe used in angioplasty for the treatment of occluded blood vessels withtortuous or kinked paths, or where the vessels may be subject todeflection or deformation at or near the position of the stent. Thestent could also be used for the repair of damaged blood vessels, forexample in aortic grafting procedures or after perforation during apercutaneous procedure. In certain such cases, the intermediate portionof the device can allow the device to conform to the shape of the bloodvessel and to deform in response to movement of the vessel with reducedrisk of fatigue failure while remaining fixed or anchored in position bythe end portions. For another example, the devices could be used to forma shunt between a healthy artery and a healthy vein for dialysis accessand/or access for administration of medications (e.g., intermittentinjection of cancer therapy, which can damage vessels).

Referring again to FIGS. 4 and 7, blocking material 251 may be used tohelp inhibit or prevent reversal of arterial blood flow. As will now bedescribed in further detail, additional or other methods and systems canbe used to inhibit or prevent reversal of arterial blood flow, or,stated another way, to inhibit or prevent flow of arterial blood nowflowing into the vein from flowing in the normal, pre-proceduredirection of blood flow in the vein such that oxygenated blood bypassesdownstream tissue such as the foot.

In the absence of treatment, Peripheral Vascular Disease (PVD) mayprogress to critical limb ischemia (CLI), which is characterized byprofound chronic pain and extensive tissue loss that restrictsrevascularization options and frequently leads to amputation. CLI isestimated to have an incidence of approximately 50 to 100 per 100,000per year, and is associated with mortality rates as high as 20% at 6months after onset.

Interventional radiologists have been aggressively trying to treat CLIby attempting to open up chronic total occlusions (CTOs) or bypassingCTOs in the sub-intimal space using such products as the MedtronicPioneer catheter, which tunnels a wire into the sub-intimal spaceproximal to the CTO and then attempts to re-enter the vessel distal tothe occlusion. Once a wire is in place, a user can optionally create awider channel and then place a stent to provide a bypass conduit pastthe occlusion. Conventional approaches such as percutaneous transluminalangioplasty (PTA), stenting, and drug eluting balloons (DEB) to treatPAD can also or alternatively be used in CLI treatment if a wire is ableto traverse the occlusion.

From the amputee-coalition.org website, the following are somestatistics regarding the CLI problem:

-   -   There are nearly 2 million people living with limb loss in the        United States.    -   Among those living with limb loss, the main causes are:        -   vascular disease (54%) (including diabetes and peripheral            artery disease (PAD)),        -   trauma (45%), and        -   cancer (less than 2%).    -   Approximately 185,000 amputations occur in the United States        each year.    -   Hospital costs associated with having a limb amputated totaled        more than $6.5 billion in 2007.    -   Survival rates after an amputation vary based on a variety of        factors. Those who have amputations due to vascular disease        (including PAD and diabetes) face a 30-day mortality rate        reported to be between 9% and 15% and a long-term survival rate        of 60% at 1 year, 42% at 3 years, and 35%-45% at 5 years.    -   Nearly half of the people who lose a limb to dysvascular disease        will die within 5 years. This is higher than the 5-year        mortality rate experienced by people with colorectal, breast,        and prostate cancer.    -   Of people with diabetes who have a lower-limb amputation, up to        55% will require amputation of the second leg within 2 to 3        years.

CLI has been surgically treated by open-leg venous arterialization sincethe early 1900's. Numerous small series of clinical trials have beenpublished over the years using such an open-leg surgical approach, assummarized by a 2006 meta-analysis article by Lu et al. in the EuropeanJournal of Vascular and Endovascular Surgery, vol. 31, pp. 493-499,titled “Meta-analysis of the clinical effectiveness of venousarterialization for salvage of critically ischemic limbs.” The articlehad the following results and conclusions:

-   -   Results:        -   A total of 56 studies were selected for comprehensive            review. No randomized control trial (RCT) was identified.            Seven patient series, comprising 228 patients, matched the            selection criteria. Overall 1-year foot preservation was 71%            (95% CI: 64%-77%) and 1-year secondary patency was 46% (95%            CI: 39%-53%). The large majority of patients in whom major            amputation was avoided experienced successful wound healing,            disappearance of rest pain, and absence of serious            complications.    -   Conclusions:        -   On the basis of limited evidence, venous arterialization may            be considered as a viable alternative before major            amputation is undertaken in patients with “inoperable”            chronic critical leg ischemia.

Among other maladies as described herein, the methods and systemsdescribed herein may be used to create an arterio-venous (AV) fistula inthe below-the-knee (BTK) vascular system using an endovascular,minimally invasive approach. Such methods may be appropriate forpatients that (i) have a clinical diagnosis of symptomatic critical limbischemia as defined by Rutherford 5 or 6 (severe ischemic ulcers orfrank gangrene); (ii) have been assessed by a vascular surgeon andinterventionist and it was determined that no surgical or endovasculartreatment is possible; and/or (iii) are clearly indicated for majoramputation.

In some embodiments, a system or kit optionally comprises one or more ofthe following components: a first ultrasound catheter (e.g., an arterialcatheter, a launching catheter including a needle, etc.); a secondultrasound catheter (e.g., a venous catheter, a target catheter, etc.);and a prosthesis (e.g., a covered nitinol stent graft in a deliverysystem (e.g., a 7 Fr (approx. 2.3 mm) delivery system)). The system orkit optionally further comprises an ultrasound system, a control system(e.g., computer). Some users may already have an appropriate ultrasoundsystem that can be connected to the ultrasound catheter(s). Thecatheters and prostheses described above may be used in the system orkit, and details of other, additional, and/or modified possiblecomponents are described below.

FIG. 14A is a schematic side cross-sectional view of an exampleembodiment of an ultrasound launching catheter 170 comprising a needle172 (e.g., a first ultrasound catheter, an arterial catheter (e.g., ifextending a needle from artery into vein), a venous catheter (e.g., ifextending a needle from vein into artery)). The catheter 170 is placedinto an artery with the needle 172 in a retracted state inside a lumenof the catheter 170. The catheter 170 can be tracked over a guidewire(e.g., a 0.014 inch (approx. 0.36 mm) guidewire) and/or placed through asheath in the artery (e.g., a femoral artery), and advanced up to thepoint of the total occlusion of the artery (in the tibial artery). Thecatheter 170 includes a handle 174 that includes a pusher ring 176.Longitudinal or distal advancement of the pusher ring 176 can advancethe needle 172 from out of a lumen of the catheter 170, out of theartery and into a vein, as described herein. Other advancementmechanisms for the needle 172 are also possible (e.g., rotational,motorized, etc.). Before, after, and/or during after advancing theneedle 172, a guidewire (e.g., a 0.014 inch (approx. 0.36 mm) guidewire)can be placed through the needle 172 (e.g., as described with respect tothe guidewire 14 of FIG. 3), and this guidewire can be referred to as acrossing wire.

FIG. 14B is an expanded schematic side cross-sectional view of a distalportion of the ultrasound launching catheter 170 of FIG. 14A within thecircle 14B. Upon advancing or launching, the needle 172 extends radiallyoutwardly from a lumen 173 of the catheter 170. In some embodiments, thelumen 173 ends proximal to the ultrasound transmitting device 178. Theneedle 172 may extend along a path that is aligned with (e.g., parallelto) the path of the directional ultrasound signal emitted by theultrasound transmitting device 178. FIG. 14B also shows the lumen 175,which can be used to house a guidewire for tracking the catheter 170 tothe desired position.

FIG. 15A is a schematic side elevational view of an example embodimentof an ultrasound target catheter 180 (e.g., a second ultrasoundcatheter, an arterial catheter (e.g., if extending a needle from veininto artery), a venous catheter (e.g., if extending a needle from arteryinto vein)). FIG. 15B is an expanded schematic side cross-sectional viewof the ultrasound target catheter 180 of FIG. 15A within the circle 15B.FIG. 15C is an expanded schematic side cross-sectional view of theultrasound target catheter 180 of FIG. 15A within the circle 15C. Thecatheter 180 can be tracked over a guidewire (e.g., a 0.014 inch(approx. 0.36 mm) guidewire) and/or placed through a sheath in the vein(e.g., a femoral vein), and advanced up to a point (e.g., in the tibialvein) proximate and/or parallel to the distal end of the catheter 170and/or the occlusion in the artery. The catheter 180 includes anultrasound receiving transducer 182 (e.g., an omnidirectional ultrasoundreceiving transducer) that can act as a target in the vein for aligningthe needle 172 of the catheter 170. The catheter 180 may be left inplace or remain stationary or substantially stationary while thecatheter 170 is rotated and moved longitudinally to obtain a good oroptimal ultrasound signal indicating that the needle 172 is aligned withand in the direction of the catheter 180.

The catheters 170, 180 may be connected to an ultrasound transceiverthat is connected to and controlled by a computer running transceiversoftware. As described in further detail herein, the catheter 170includes a flat or directional ultrasound transmitter 178 configured totransmit an ultrasound signal having a low angular spread or tight beam(e.g., small beam width) in the direction of the path of the needle 172upon advancement from the lumen 173 of the catheter 170. The catheter180 includes an omnidirectional (360 degrees) ultrasound receiver 182configured to act as a target for the ultrasound signal emitted by thedirectional transmitter 178 of the catheter 170. The catheter 170 isrotated until the peak ultrasound signal is displayed, indicating thatthe needle 172 is aligned to the catheter 180 such that, upon extensionof the needle 172 (e.g., by longitudinally advancing the ring 176 of thehandle 174), the needle 172 can pass out of the artery in which thecatheter 170 resides, through interstitial tissue, and into the vein inwhich the catheter 180 resides.

FIG. 16 is an example embodiment of a graph for detecting catheteralignment, as may be displayed on display device of an ultrasound system(e.g., the screen of a laptop, tablet computer, smartphone, combinationsthereof, and the like). The graph in FIG. 16 shows that the signaloriginating from the transmitting catheter in the artery has beenreceived by the receiving catheter in the vein. The second frequencyenvelope from the right is the received signal. The distance from theleft side of the illustrated screen to the leading edge of the secondfrequency envelope may indicate the distance between the catheters. Theoperator can move the catheter in the artery both rotationally andlongitudinally, for example until the second envelope is maximal, whichindicates the catheters are correctly orientated.

FIG. 17 is a schematic side elevational view of an example embodiment ofa prosthesis (e.g., stent, stent-graft) delivery system 190. In someembodiments, the delivery system 190 is a 7 Fr (approx. 2.3 mm) deliverysystem. FIG. 18 is a schematic side elevational view of an exampleembodiment of a prosthesis (e.g., stent, stent-graft) 200. In FIG. 17, aprosthesis (e.g., the prosthesis 200, other prostheses described herein,etc.) is in a compressed or crimped state proximate to the distal end192 of the delivery system 190. In some embodiments, the prosthesis 200comprises a shape-memory stent covered with a graft material, forexample as described above. Once the crossing wire extends from theartery to the vein, for example as a result of being advanced throughthe needle 172 as described herein, the delivery system 190 can beadvanced over the crossing wire. The prosthesis 200 may be deployed fromthe delivery system 190, for example by squeezing the trigger handle 194of the delivery system 190, causing the outer cover sheath to proximallyretract and/or distally advance the prosthesis 200. The prosthesis 200can create a flow path between the artery and the vein and through theinterstitial tissue. Other types of delivery systems and prostheses arealso possible.

Referring again to FIG. 17, some non-limiting example dimensions of thedelivery system 190 are provided. The distance 196 of travel of thetrigger handle 194 may be, for example, between about 0.4 inches(approx. 1 cm) and about 12 inches (approx. 30 cm), between about 1 inch(approx. 2.5 cm) and about 8 inches (approx. 20 mm), or between about 2inches (approx. 5 cm) and about 6 inches (approx. 15 mm) (e.g., about 2inches (approx. 5 cm)). In some embodiments, the distance 196 of travelof the trigger handle 194 is at least as long as the length of theprosthesis 200 to be deployed (e.g., in the radially expanded state). Insome embodiments, gearing or other mechanisms may be employed to reducethe distance 196 of travel of the trigger handle 194 be less than thelength of the prosthesis 200 to be deployed (e.g., in the radiallyexpanded state). The distance 196 may be adjusted for example, based onat least one of: the length of the prosthesis 200 to be deployed, thedegree of foreshortening of the prosthesis 200 to be deployed, themechanism of deployment (e.g., whether the outer sheath is proximallyretracted, the prosthesis 200 is pushed distally forward, or both,whether the delivery system 190 includes gearing mechanism, etc.),combinations thereof, and the like. The length 197 of the outer sheathor catheter portion may be, for example, between about 40 inches(approx. 1,020 mm) and about 50 inches (approx. 1,270 mm), between about46 inches (approx. 1,170 mm) and about 47 inches (approx. 1,190 mm), orbetween about 46.48 inches (approx. 1,180 mm) and about 46.7 inches(approx. 1,186 mm). The total length 198 of the delivery system 190 fromproximal tip to distal tip may be, for example, between about 40 inches(approx. 1,000 mm) and about 60 inches (approx. 1,500 mm). The lengths197, 198 may be adjusted, for example based on at least one of: lengthof the prosthesis 200 to be deployed, the degree of foreshortening ofthe prosthesis 200 to be deployed, the height of the patient, thelocation of the occlusion being treated, combinations thereof, and thelike. In some embodiments, spacing the trigger handle 194 from thevascular access point, for example by between about 10 cm and about 30cm (e.g., at least about 20 cm) may advantageously provide easierhandling or management by the user. In certain such embodiments, thelength 197 may be between about 120 cm and about 130 cm (e.g., for anantegrade approach) or between about 150 cm and about 180 cm (e.g., fora contralateral approach).

Referring again to FIG. 18, some non-limiting example dimensions of theprosthesis 200 are provided, depending on context at least in thecompressed state. The thickness 201 of a structural strut may be, forexample, between about 0.05 mm and about 0.5 mm or between about 0.1 mmand about 0.2 mm (e.g., about 0.143 mm). The spacing 202 between strutsof a structural strut may be, for example, between about 0.005 mm andabout 0.05 mm or between about 0.01 mm and about 0.03 mm (e.g., about0.025 mm). The thickness 203 of a linking strut may be, for example,between about 0.05 mm and about 0.5 mm or between about 0.1 mm and about0.2 mm (e.g., about 0.133 mm). The longitudinal length 204 of thestructural components may be, for example, between about 1 mm and about5 mm or between about 2.5 mm and about 3 mm (e.g., about 2.8 mm). Thelongitudinal length 205 between structural components may be, forexample, between about 0.25 mm and about 1 mm or between about 0.5 mmand about 0.6 mm (e.g., about 0.565 mm). The length 206 of a strutwithin a structural component, including all portions winding back andforth, may be, for example, between about 25 mm and about 100 mm orbetween about 65 mm and about 70 mm (e.g., about 67.62 mm). The totallongitudinal length of the prosthesis 200 may be, for example, betweenabout 25 mm and about 150 mm or between about 50 mm and about 70 mm(e.g., about 62 mm). As described herein, a wide variety of laser-cutstents, woven stents, and combinations thereof, including variousdimensions, are possible. The struts described herein may comprise wiresor filaments or potions not cut from a hypotube or sheet.

The proximal and/or distal ends of the prosthesis 200 may optionallycomprise rings 210. The rings 210 may, for example, help to anchor theprosthesis 200 in the artery and/or the vein. The circumferential width211 of a ring 210 may be, for example, between about 0.25 mm and about 1mm or between about 0.5 mm and about 0.75 mm (e.g., about 0.63 mm). Thelongitudinal length 212 of a ring 210 may be, for example, between about0.25 mm and about 2 mm or between about 0.5 mm and about 1 mm (e.g.,about 0.785 mm). In some embodiments, a ratio of the total length of theprosthesis 200 to the longitudinal length 212 of a ring 210 may bebetween about 50:1 and about 100:1 (e.g., about 79:1). The dimensions211, 212 of the rings 210 may be adjusted, for example based on at leastone of: strut thickness, diameter of the prosthesis (e.g., relative tothe vessel), total length of the prosthesis, material, shape settingproperties, combinations thereof, and the like.

FIG. 19 is a schematic side elevational view of another exampleembodiment of a prosthesis 220. The prosthesis 200 may have the shape ofthe prosthesis 220, for example in a radially expanded state (e.g., uponbeing deployed from the delivery system 190). FIG. 19 illustrates anexample shape of the prosthesis 220 comprising a first portion 221 and asecond portion 225. The first portion 221 has a substantiallycylindrical or cylindrical shape having a length 222 between about 15 mmand about 25 mm (e.g., about 21 mm) and a diameter 223 between about 2.5mm and about 5 mm (e.g., about 3.5 mm). The second portion 225 has asubstantially frustoconical or frustoconical shape having a length 226between about 30 mm and about 50 mm (e.g., about 41 mm) and a widestdiameter 227 between about 4 mm and about 10 mm, between about 4 mm andabout 7 mm (e.g., about 5.5 mm), etc. The angle of taper of the secondportion 225 away from the first portion 221 may be between about 0.02degrees and about 0.03 degrees (e.g., about 0.024 degrees).

Further details regarding prostheses that can be used in accordance withthe methods and systems described herein are described in U.S. patentapplication Ser. No. 13/791,185, filed Mar. 8, 2013, which is herebyincorporated by reference in its entirety.

FIGS. 20A-20H schematically illustrate an example embodiment of a methodfor effecting retroperfusion. The procedure will be described withrespect to a peripheral vascular system such as the lower leg, but canalso be adapted as appropriate for other body lumens (e.g., cardiac,other peripheral, etc.). Certain steps such as anesthesia, incisionspecifics, suturing, and the like may be omitted for clarity. In someembodiments, the procedure can be performed from vein to artery (e.g.,with the venous catheter coming from below).

Access to a femoral artery and a femoral vein is obtained. An introducersheath (e.g., 7 Fr (approx. 2.3 mm)) is inserted into the femoral arteryand an introducer sheath (e.g., 6 Fr (approx. 2 mm)) is inserted intothe femoral vein, for example using the Seldinger technique. A guidewire(e.g., 0.014 inch (approx. 0.36 mm), 0.035 inch (approx. 0.89 mm), 0.038inch (approx. 0.97 mm)) is inserted through the introducer sheath in thefemoral artery and guided into the distal portion of the posterior oranterior tibial diseased artery 300. A second guidewire (e.g., 0.014inch (approx. 0.36 mm), 0.035 inch (approx. 0.89 mm), 0.038 inch(approx. 0.97 mm)) or a snare is inserted through the introducer sheathin the femoral vein. In embodiments in which a snare is used, thedescribed third guidewire, fourth guidewire, etc. described herein areaccurate even though the numbering may not be sequential.

A venous access needle is percutaneously inserted into a target vein,for example a tibial vein (e.g., the proximal tibial vein (PTV)). Insome embodiments, the venous access needle may be guided underultrasound. In some embodiments, contrast may be injected into thesaphenous vein towards the foot (retrograde), and then the contrast willflow into the PTV. This flow path can be captured using fluoroscopy suchthat the venous access needle can be guided by fluoroscopy rather thanor in addition to ultrasound.

The target vein may be accessed proximate to and distal to (e.g., a fewinches or centimeters) below where the launching catheter 310 willlikely reside. In some embodiments, the target vein may be in the ankle.Once the venous access needle is in the vein, a third guidewire (or“second” guidewire in the case that a snare is used instead of a secondguidewire) is inserted into the venous access needle and advancedantegrade in the target vein up to the femoral vein. This access methodcan advantageously reduce issues due to advancing wires retrogradeacross venous valves, which are described in further detail below. Thethird guidewire is snared, for example using fluoroscopic guidance, andpulled through the femoral vein sheath. The target catheter 320 isinserted into the femoral vein sheath over the third guidewire, whichhas been snared. The target catheter 320 is advanced over the thirdguidewire into the venous system until the target catheter is proximateto and/or parallel with the guidewire in the distal portion of theposterior or anterior tibial diseased artery and/or proximate to theocclusion 304, as shown in FIG. 20A.

In some embodiments, the third guidewire may include an ultrasoundreceiving transducer (e.g., omnidirectional) mounted to provide thetarget for the signal emitted by the launching catheter 310 or thetarget catheter 320 could be tracked over the third guidewire, either ofwhich may allow omission of certain techniques (e.g., femoral veinaccess, introducing vein introducer sheath, inserting second guidewire,antegrade advancing of the third guidewire up to the femoral vein,snaring the third guidewire, advancing the target catheter 320 over thethird guidewire).

In some embodiments, the PTV may be accessed directly, for example usingultrasound, which can allow placement of the target catheter 320directly into the PTV, for example using a small sheath, which may allowomission of certain techniques (e.g., femoral vein access, introducingvein introducer sheath, inserting second guidewire, antegrade advancingof the third guidewire up to the femoral vein).

In some embodiments, the catheter 320 is not an over-the-wire catheter,but comprises a guidewire and an ultrasound receiving transducer (e.g.,omnidirectional). The catheter 320 may be inserted as the thirdguidewire, as discussed above, as the second guidewire, or as aguidewire through a small sheath when directly accessing the PTV.

Ultrasound transducers generally include two electrodes includingsurfaces spaced by a ceramic that can vibrate. An incoming or receivedultrasound signal wave can couple into a length extensional mode, asshown in FIG. 21. FIG. 21 is a schematic perspective view of an exampleembodiment of an ultrasound receiving transducer 350. If the proximal ortop end 352 of the transducer 350 and the distal or bottom end 354 ofthe transducer are conductive and electrically connected to wires, thetransducer can receive ultrasound signals. In some embodiments, thetransducer 350 has a length 356 between about 0.1 mm and about 0.4 mm(e.g., about 0.25 mm). In some embodiments, the transducer 350 has anoverlap length 358 between about 0.1 mm and about 0.3 mm (e.g., about0.2 mm). In some embodiments, the transducer 350 has a diameter that issimilar to, substantially similar to, or the same as the guidewire onwhich it is mounted. In some embodiments, an array or series oflaminates may enhance the signal-receiving ability of the transducer350.

In some embodiments, a guidewire comprising an ultrasound receivingtransducer may comprise a piezoelectric film (e.g., comprising plastic),which could enhance the signal-receiving ability of the transducer. FIG.22 is a schematic cross-sectional view of another example embodiment ofan ultrasound receiving transducer 360. The ultrasound receivingtransducer 360 shown in FIG. 22 includes an optional lumen 368. Theultrasound receiving transducer 360 includes a series of layers 362,364, 366. The layer 362 may comprise a polymer (e.g., polyvinylidenefluoride (PVDF)) layer. The layer 364 may comprise an inorganic compound(e.g., tungsten carbide) layer. The layer 366 may comprise a polymer(e.g., polyimide) layer. The layer 366 may have a thickness betweenabout 25 micrometers (μm or microns) and about 250 μm (e.g., at leastabout 50 μm).

The launching catheter 310 is tracked over the guidewire in the femoraland tibial arteries proximate to and proximal to the occlusion 304, asshown in FIG. 20B. The catheter 310 may be more proximal to theocclusion 304 depending on suitability at that portion of the anatomyfor the retroperfusion process. In some embodiments, the catheter 310may be positioned in the distal portion of the posterior or anteriortibial artery, for example proximate to the catheter 320. In someembodiments, the catheter 310 may be positioned within a few inches orcentimeters of the ankle.

The launching catheter 310 emits a directional ultrasound signal. Asshown by the arrow 311, 312 in FIG. 20C, the launching catheter 310 isrotated and moved longitudinally until the signal is received by thetarget catheter 320. Once the signal is received, which indicatesalignment such that extension of the needle form the launching catheter310 will result in successful access of the vein, a crossing needle 314is advance out of the catheter 310, out of the tibial artery 300 andinto the tibial vein 302, as shown in FIG. 20D. Accuracy of theplacement of the crossing needle 314 to form a fistula between theartery 300 and the vein 302 may be confirmed, for example, usingcontrast and fluoroscopy.

In some embodiments, the ultrasound signal can be used to determine thedistance between the artery 300 and the vein 302. Referring again toFIG. 16, the distance from the left side of the illustrated screen tothe leading edge of the second frequency envelope can be used as anindicator of distance between the catheters.

Referring again to FIG. 16, a display device may graphically show signalalignment peaks to allow the user to determine the alignment position.In some embodiments, the signal alignment may change color above orbelow a threshold value, for example from red to green. In someembodiments, an audio signal may be emitted, for example when analignment signal crosses over a threshold value, which can allow a userto maintain focus on the patient rather than substantially continuouslymonitoring a screen.

In some embodiments, a horizontal line on the screen may move up toindicate the maximum signal value or peak achieved to that point duringthe procedure. This line may be called “peak hold.” If a greater signalvalue is achieved, the horizontal line moves to match that higher value.If no manipulation is able to raise the peak above the horizontal line,that can indicate maximum alignment. If the signal peak falls a certainamount below the horizontal line, the catheters may have moved and nolonger be properly aligned. Since the level of alignment indicated bythe horizontal line has previously been achieved during the procedure,the user knows that such a level of alignment can be achieved by furtherrotational and/or longitudinal manipulation.

A fourth guidewire 316 (e.g., 0.014 inch (approx. 0.36 mm)) (or “third”guidewire in the case that a snare is used instead of a secondguidewire) is placed through the lumen of the crossing needle 314 of thecatheter 310 and into the tibial vein 302 in a retrograde direction (ofthe vein 302) towards the foot, as shown in FIG. 20E. External cuffpressure may be applied above the needle crossing point to reduce flowin the artery 300 to inhibit or prevent formation of a hematoma, and/orto engorge the vein to facilitate valve crossing. The catheters 310, 320may be removed, leaving the guidewire 316 in place, extending from theintroducer sheath in the femoral artery, through the arterial tree, andinto the tibial vein 302.

Certain techniques for crossing a guidewire 316 from an artery 300 to avein 302 may be used instead of or in addition to the directionalultrasound techniques described herein.

In some embodiments, a tourniquet can be applied to the leg, which canincrease vein diameters. In some embodiments, a blocking agent (e.g., asdiscussed with respect to FIGS. 4 and 7, a blocking balloon, etc.) maybe used to increase vein diameter. For example, venous flow could backup, causing dilation of the vein. A larger vein diameter can produce alarger target for the crossing needle 314, making the vein 300 easier toaccess with the crossing needle 314.

In some embodiments, a PTA balloon can be used in the target vein, and aneedle catheter (e.g., Outback, available from Cordis) can target thePTA balloon under fluoroscopy. The crossing needle 314 can puncture thePTA balloon, and the reduction in pressure of the PTA balloon canconfirm proper alignment of the crossing needle 314. The PTA balloon canincrease vein diameter, producing a larger target for the crossingneedle 314, making the vein 300 easier to access with the crossingneedle 314. The guidewire 316 may be advanced through the crossingneedle 314 and into the PTA balloon.

In some embodiments, the PTA balloon comprises a mesh (e.g., a wovenmesh), for example embedded in the polymer of the balloon. When aballoon without such a mesh is punctured, the balloon material couldrupture and cause emboli (e.g., pieces of the balloon floatingdownstream). The mesh can help to limit tearing of the balloon material,which can inhibit or prevent balloon material from causing emboli.

In some embodiments, two PTA balloons spaced longitudinally along theaxis of the catheter can be used in the target vein, and a needlecatheter can target the one of the PTA balloons. Upon puncturing of oneof the PTA balloons by the crossing needle 314, contrast in a wellbetween the PTA balloons can be released because the punctured balloonno longer acts as a dam for the contrast. The release of contrast can bemonitored using fluoroscopy. The PTA balloons can be on the samecatheter or on different catheters.

In some embodiments, two PTA balloons spaced longitudinally along theaxis of the catheter can be used in the target vein, and a needlecatheter can target the space or well between the PTA balloons. Uponpuncturing of the well by the crossing needle 314, contrast in the wellcan be disturbed. The disturbance of contrast can be monitored usingfluoroscopy. The PTA balloons can be on the same catheter or ondifferent catheters.

In some embodiments in which a PTA balloon may be used in combinationwith an ultrasound target in the target vein, a PTA balloon catheterincludes a PTA balloon and an ultrasound receiving transducer (e.g.,omnidirectional). In certain such embodiments, the launching catheter310 can target the PTA balloon under fluoroscopy and/or can target theultrasound receiving transducer as described herein. The crossing needle314 can puncture the PTA balloon, and the reduction in pressure of thePTA balloon can confirm proper alignment of the crossing needle 314. ThePTA balloon can increase vein diameter, producing a larger target forthe crossing needle 314, making the vein 300 easier to access with thecrossing needle 314. The guidewire 316 may be advanced through thecrossing needle 314 and into the PTA balloon.

In some embodiments, a LeMaitre device (e.g., the UnBalloon™Non-Occlusive Modeling Catheter, available from LeMaitre Vascular ofBurlington, Mass.) can be used in the target vein. In some embodiments,a LeMaitre device can increase vein diameters. A larger vein diametercan produce a larger target for the crossing needle 314, making the vein300 easier to access with the crossing needle 314. In some embodiments,the needle 314 can penetrate into the LeMaitre device. In certain suchembodiments, the LeMaitre device can act as a mesh target (e.g.,comprising radiopaque material visible under fluoroscopy) for thecrossing needle 314. The mesh of the LeMaitre device can be radiallyexpanded by distally advancing a proximal portion of the mesh and/orproximally retracting a distal portion of the mesh (e.g., pushing theends together like an umbrella) and/or by allowing the mesh toself-expand (e.g., in embodiments in which at least some parts of themesh comprise shape-memory material). In some embodiments, a LeMaitredevice can grip a crossing wire to hold the crossing wire in the targetvein as the LeMaitre device closes.

In some embodiments, the launching catheter 310 may comprise a firstmagnet having a first polarity and the target catheter 320 may comprisea second magnet having a second polarity. When the magnets are closeenough for magnetic forces to move one or both of the catheters 310,320, the crossing needle 314 may be advanced to create the fistulabetween the artery 300 and the vein 302. In some embodiments, the firstmagnet maybe circumferentially aligned with the crossing needle 314and/or the launching catheter 310 may be magnetically shielded toprovide rotational alignment. In some embodiments, the second magnet maybe longitudinally relatively thin to provide longitudinal alignment. Insome embodiments, the crossing needle 314 and/or the guidewire 316 maybe magnetically pulled from the artery 300 to the vein 302, or viceversa. Some systems may include both ultrasound guidance and magneticguidance. For example, ultrasound guidance could be used for initialalignment and magnetic guidance could be used for refined alignment.

Referring again to FIGS. 20A-20H, a prosthesis delivery system 330carrying a prosthesis 340 is tracked over the guidewire 316 through theinterstitial space between the artery 300 and the vein 300 and then intothe vein 300, as shown in FIG. 20F. In some embodiments, a separate PTAballoon catheter (e.g., about 2 mm) can be tracked over the guidewire316 to pre-dilate the fistula between the artery 300 and the vein 302prior to introduction of the prosthesis delivery system 330. Use of aPTA balloon catheter may depend, for example, on the radial strength ofthe prosthesis 340.

The prosthesis 340 is deployed from the prosthesis delivery system 330,for example by operating a trigger handle 194 (FIG. 17). In someembodiments, for example if the prosthesis 340 is not able to expandand/or advance, the prosthesis delivery system 330 may be removed and aPTA catheter (e.g., about 2 mm) advanced over the guidewire 316 toattempt to dilate or further dilate the fistula the artery 300 and thevein 302. Deployment of the prosthesis 340 may then be reattempted(e.g., by self-expansion, balloon expansion, etc.). In some embodiments,deployment of the prosthesis 340 may remodel a vessel, for exampleexpanding the diameter of the vessel by at least about 10%, by at leastabout 20%, by at least about 30%, or more, by between about 0% and about10%, by between about 0% and about 20%, by between about 0% and about30%, or more. In embodiments in which the prosthesis 340 isself-expanding, the degree of remodeling may change over time, forexample the prosthesis 340 expanding as the vessel expands orcontracting when the vessel contracts.

Once the prosthesis 340 is deployed, as shown in FIG. 20G, the fistulamay be dilated with a PTA catheter. The diameter of the PTA catheter(e.g., about 3 mm to about 6 mm) may be selected based at least in parton: the diameter of the artery 300, the diameter of the vein 302, thecomposition of the interstitial tissue, the characteristics of theprosthesis 340, combinations thereof, and the like. In some embodiments,the prosthesis delivery system 330 may comprise a PTA balloon catheter(e.g., proximal or distal to the prosthesis 340) usable for one,several, or all of the optional PTA balloon catheter techniquesdescribed herein. In embodiments in which the prosthesis comprises aconical portion, the PTA balloon may comprise a conical portion. Oncethe prosthesis 340 is in place, the prosthesis delivery system 330 maybe removed, as shown in FIG. 20H. An AV fistula is thereby formedbetween the artery 300 and the vein 302. Confirmation of placement ofvarious catheters 310, 320, 330 and the prosthesis 340 may be confirmedthroughout parts or the entire procedure under fluoroscopy usingcontrast injections.

In some embodiments, a marker (e.g., a clip a lancet, scissors, apencil, etc.) may be applied (e.g., adhered, placed on top of, etc.) tothe skin to approximately mark the location of the fistula formedbetween the artery 300 and the vein 302 by the crossing needle 314 priorto deployment of the prosthesis 340. In embodiments in which the useruses a sphygmomanometer inflated above the fistula to avoid bleeding,the lack of blood flow can render visualization or even estimation ofthe fistula site difficult, and the marker can provide suchidentification. In embodiments in which the transmitting and receivingcatheters are removed after fistula formation, the cross-over point maybe difficult for the user to feel or determine, and the marker canprovide such identification. If the fistula is to be dilated, a midpointof the dilation balloon may be preferably aligned with the midpoint ofthe fistula (e.g., to increase or maximize the hole-through interstitialspace). In some embodiments, the marker may be visualized underfluoroscopy (e.g., comprising radiopaque material) to allow the user tosee and remember the location of the fistula under fluoroscopy prior todeployment of the prosthesis 340.

Once the prosthesis 340 is in place, an obstacle to blood flowingthrough the vein 302 and into the foot are the valves in the veins.Steering a guidewire across venous valves can be a challenge, forexample because pressure from the artery may be insufficient to extendthe veins and make the valves incompetent. The Applicant has discoveredthat venous valves distal to the AV fistula can be disabled or madeincompetent using one or more of a variety of techniques such as PTAcatheters, stents, and a valvulotome, as described in further detailbelow. Disabling venous valves can allow blood to flow viaretroperfusion from the femoral artery, retrograde in the vein 302, andretrograde in the vein to the venules and capillaries to the distal partof the venous circulation of the foot to provide oxygenated blood to thefoot in CLI patients.

In some embodiments, a high-pressure PTA balloon catheter may be used tomake venous valves incompetent (e.g., when inflated to greater thanabout 10 atm (approx. 1,013 kPa)).

In some embodiments, one or more stents can be placed across one or morevenous valves to render those valves incompetent. For example, suchstents should have sufficient radial force that the valves stay open.

In some in situ bypass procedures, a saphenous vein is attached to anartery in the upper leg and another artery in the lower leg, bypassingall blockages in the artery. In certain such procedures, the vein is notstripped out of the patient, flipped lengthwise, and used as aprosthesis, but rather is left in place so that blood flow is retrograde(against the valves of the vein). A standard valvulotome may be placedinto the saphenous vein from below and advanced to the top in acollapsed state, opened, and then pulled backwards in an open state,cutting venous valves along the way. Cutting surfaces of suchvalvulotomes face backwards so as to cut during retraction during theseprocedures. FIG. 23A is a schematic perspective view of an exampleembodiment of a valvulotome 400 that may be used with such procedures,including blades 402 facing proximally.

In some embodiments of the methods described herein, access distal tothe vein valves is not available such that pulling a valvulotomebackwards is not possible, but pushing a reverse valvulotome asdescribed herein forward is possible. FIG. 23B is a schematicperspective view of an example embodiment of a valvulotome 410 that maybe used with such procedures. The reverse valvulotome 410 includes oneor a plurality of blades 412 (e.g., two to five blades (e.g., threeblades)) facing forward or distal such that valves can be cut as thereverse valvulotome 410 is advanced distally. At least becauseretrograde access to veins to be disabled has not previously beenrecognized as an issue, there has been no prior motivation to reversethe direction of the blades of a valvulotome to create a reversevalvulotome 410 such as described herein. The reverse valvulotome 410may be tracked over a guidewire 414, which can be steered into theveins, for making the venous valves incompetent. After forming a fistulabetween an artery and a vein as described herein, the flow of fluid inthe vein is in the direction opposite the native or normal orpre-procedure direction of fluid flow in the vein such that pushing thereverse valvulotome 410 is in a direction opposite native fluid flow butin the direction of post-fistula fluid flow.

Other systems and methods are also possible for making the valves in thevein incompetent (e.g., cutting balloons, atherectomy, laser ablation,ultrasonic ablation, heating, radio frequency (RF) ablation, a catheterwith a tip that is traumatic or not atraumatic (e.g., an introducersheath) being advanced and/or retracted, combinations thereof, and thelike).

Crossing vein valves in a retrograde manner before such valves are madeincompetent can also be challenging. FIG. 24 is a schematic perspectiveview of an example embodiment of a LeMaitre device 420 that may be usedto radially expand the veins, and thus their valves. The LeMaitre device420 includes an expandable oval or oblong leaf shape 422, for example aself-expanding nitinol mesh. In some embodiments, a PTA balloon cathetermay be used to radially expand the veins, and thus their valves. In someembodiments, application of a tourniquet to the leg can radially expandthe veins, and thus their valves. Upon radial expansion, a guidewire canbe advanced through the stretched valve(s) (e.g., through an expansiondevice such as the LeMaitre device) and catheters (e.g., PTA, stentdelivery, atherectomy, etc.) or other over-the-wire devices can beadvanced over the guidewire.

Although some example embodiments have been disclosed herein in detail,this has been done by way of example and for the purposes ofillustration only. The aforementioned embodiments are not intended to belimiting with respect to the scope of the appended claims, which follow.It is contemplated by the inventors that various substitutions,alterations, and modifications may be made to the invention withoutdeparting from the spirit and scope of the invention as defined by theclaims.

While the devices described herein may be used in applications in whichthe fluid that flows through the device is a liquid such as blood, thedevices could also or alternatively be used in applications such astracheal or bronchial surgery where the fluid is a gas, such as air. Insome embodiments, the fluid may contain solid matter, for example embolior, in gastric surgery where the fluid includes food particles.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but, to the contrary, the invention is to coverall modifications, equivalents, and alternatives falling within thespirit and scope of the various embodiments described and the appendedclaims. Any methods disclosed herein need not be performed in the orderrecited. The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “making valves in the first vessel incompetent” include“instructing making valves in the first vessel incompetent.” The rangesdisclosed herein also encompass any and all overlap, sub-ranges, andcombinations thereof. Language such as “up to,” “at least,” “greaterthan,” “less than,” “between,” and the like includes the number recited.Numbers preceded by a term such as “about” or “approximately” includethe recited numbers. For example, “about 10 mm” includes “10 mm.” Termsor phrases preceded by a term such as “substantially” include therecited term or phrase. For example, “substantially parallel” includes“parallel.”

The following claims set forth several embodiments of the invention(s).These non-limiting claims identify certain permutations of combinationsof features disclosed herein, although other permutations ofcombinations of features are also encompassed within the scope of theinvention(s).

What is claimed is:
 1. A method of targeting a second passage from afirst passage to effect retroperfusion in the second passage, the methodcomprising: expanding an expandable device in the second passage;advancing a needle from a first catheter in the first passage out of thefirst passage and into the second passage to form a fistula between thefirst passage and the second passage, wherein advancing the needlecomprises puncturing the expandable device; and making a valve in thesecond passage incompetent to reduce inhibition of retroperfusionthrough the second passage by the valve, wherein, after advancing theneedle, a first portion of the needle is in the first passage, a secondportion of the needle is in the second passage, and a third portion ofthe needle is in the fistula.
 2. The method of claim 1, furthercomprising orienting the needle towards the expandable device.
 3. Themethod of claim 1, wherein the first passage comprises a tibial artery,and wherein the second passage comprises a tibial vein.
 4. The method ofclaim 1, wherein expanding the expandable device comprisesself-expanding the expandable device.
 5. The method of claim 1, whereinmaking the valve in the second passage incompetent comprises using acutting balloon or valvulotome.
 6. The method of claim 1, furthercomprising: injecting contrast in the second passage; and monitoring thecontrast using fluoroscopy, wherein disturbance of the contrastattributable to the needle advancing into the second passage confirmsadvancement of the needle into the second passage.
 7. The method ofclaim 1, further comprising: orienting the needle towards the expandabledevice; injecting contrast in the second passage; and monitoring thecontrast using fluoroscopy, wherein disturbance of the contrastattributable to the needle advancing into the second passage confirmsadvancement of the needle into the second passage, wherein the firstpassage comprises a tibial artery, and wherein the second passagecomprises a tibial vein.
 8. A method of targeting a second passage froma first passage to effect retroperfusion in the second passage, themethod comprising: expanding an expandable device in the second passage,the expandable device comprising radiopaque material visible underfluoroscopy; advancing a needle from a first catheter in the firstpassage out of the first passage and into the second passage to form afistula between the first passage and the second passage, whereinadvancing the needle comprises: targeting the expandable device underfluoroscopy; and monitoring the needle to confirm advancement of theneedle into the second passage; and making a valve in the second passageincompetent to reduce inhibition of retroperfusion through the secondpassage by the valve.
 9. The method of claim 8, further comprisingorienting the needle towards the expandable device.
 10. The method ofclaim 8, wherein the first passage comprises a tibial artery, andwherein the second passage comprises a tibial vein.
 11. The method ofclaim 8, wherein making the valve in the second passage incompetentcomprises using a cutting balloon or valvulotome.
 12. The method ofclaim 8, further comprising injecting contrast in the second passage,wherein monitoring the needle to confirm advancement comprises:monitoring the contrast using fluoroscopy, and monitoring disturbance ofthe contrast attributable to the needle advancing into the secondpassage.
 13. The method of claim 8, further comprising: orienting theneedle towards the expandable device; and injecting contrast in thesecond passage, wherein monitoring the needle to confirm advancementcomprises: monitoring the contrast using fluoroscopy, and monitoringdisturbance of the contrast attributable to the needle advancing intothe second passage, wherein the first passage comprises a tibial artery,and wherein the second passage comprises a tibial vein.
 14. A method oftargeting a second passage from a first passage to effect retroperfusionin the second passage, the method comprising: inserting an expandabledevice in the second passage; advancing a needle from a first catheterin the first passage out of the first passage and into the secondpassage to form a fistula between the first passage and the secondpassage, wherein advancing the needle comprises targeting the expandabledevice; monitoring the expandable device as the needle is advancedtowards the expandable device to confirm advancement of the needle intothe second passage; and making a valve in the second passage incompetentto reduce inhibition of retroperfusion through the second passage by thevalve.
 15. The method of claim 14, further comprising orienting theneedle towards the expandable device.
 16. The method of claim 14,wherein the first passage comprises a tibial artery, and wherein thesecond passage comprises a tibial vein.
 17. The method of claim 14,wherein making the valve in the second passage incompetent comprisesusing a cutting balloon or valvulotome.
 18. The method of claim 14,wherein the expandable device comprises radiopaque material.
 19. Themethod of claim 14, further comprising: orienting the needle towards theexpandable device; injecting contrast in the second passage; andmonitoring the contrast, wherein disturbance of the contrastattributable to the needle advancing into the second passage confirmsadvancement of the needle into the second passage.
 20. The method ofclaim 14, further comprising: injecting contrast in the second passage;and monitoring the contrast using fluoroscopy, wherein disturbance ofthe contrast attributable to the needle advancing into the secondpassage confirms advancement of the needle into the second passage,wherein the expandable device comprises radiopaque material, wherein thefirst passage comprises a tibial artery, and wherein the second passagecomprises a tibial vein.